MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2015-12-02 for 3-HOLE WIRE CLAMP SLIDER UNIT 80031 manufactured by Orthofix Srl.
[32454836]
Analysis of historical records: the device involved in this event has not been received by orthofix srl. Unfortunately also, the batch number has not been made available, therefore, it was not possible to perform the verification of the historical data. Technical evaluation: the technical evaluation of the device involved will be performed as soon as the device becomes available. Medical evaluation: the information available on the case was sent to our medical evaluator. A preliminary medical evaluation was performed and will be finalized once further information on the event will be available. Orthofix srl has requested the distributor to provide further information on the event such as batch number of the device involved, patient's age, date of the second surgery, copies of the operative reports, copies of the pre and post operative reports (initial and second surgery), device availability for the technical evaluation. Unfortunately this information has not yet been made available. As soon as further information is available, orthofix srl will provide you with a follow up report. Orthofix srl continues monitoring the devices on the market.
Patient Sequence No: 1, Text Type: N, H10
[32454837]
The information provided by the local distributor indicates: product code: 80031 (3-hole wire clamp slider unit). Batch number: not provided. Quantity: 1. Hospital name: (b)(6). Surgeon name: not applicable. Date of surgery: not applicable. Body part to which device was applied: distal tibia. Surgery description: fracture treatment. Patient information: male, (b)(6). Problem observed during: into treatment/post-operative. Type of problem: device functional problem. Event description: the patient felt a strong pain in distal tibia then he realized that device was breaking. The screws and wires came away from the external fixator. The complaint report form also indicates: the device failure had adverse effects on patient. An additional surgery was required following device failure (date not available). Copies of the operative reports are not available. Copies of the x-rays are not available. Patient current health condition: patient is in good health conditions. Note and comments: this occurrence has been reported to the national competent authority according to resolution rdc no. (b)(4) due this complaint led a serious adverse event as an additional surgery to repair the external fixation system. (b)(4) notification/mdr #(b)(4) notified on (b)(4) 2015. On november 23, 2015, orthofix srl received the following additional information on the event: batch number of the device involved: not informed. We are going to ask customer again. Date of the initial surgery: (b)(6) 2014. Date of the device breakage: (b)(6) 2015. Patient's age: not available. Date of the second surgery: not informed. We are going to ask customer. Copies of the operative reports (initial and second surgery) and copies of the pre and post-operative x-rays (initial and second surgery): i suppose those files are not available, however i am going to ask the complainant again. 7. Device availability for the technical evaluation: we are trying to provide the device return. As soon as i am able to confirm if this device is available, i will let you know. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[39762305]
Analysis of historical records the device involved in this event has not been received by orthofix srl. Unfortunately also the batch number has not been made available, therefore it was not possible to perform the verification of the historical data. Technical evaluation a technical evaluation of the device involved was not possible as the device has not been made available. The technical evaluation will be performed as soon as the device becomes available. Medical evaluation the little information made available on the case was sent to our medical evaluator. Please find below an extract of the medical evaluation performed. "the primary problem is that the fixation was applied on (b)(6) 2014, and was on the patient continuously when a jaw of a wire clamp, 80031, broke 17. 5 months later on (b)(6) 2015. As far as we know the frame remains on the patient. The patient has had very protracted limb reconstruction of the right tibia, based primarily on a 300 mm standard lrs rail with two clamps: the proximal clamp has 3 bone screws in positions 1,3 & 5, and the distal has 2 bone screws, in positions 3 & 5. A standard cd unit is applied across these clamps, suggesting that some callotasis has been proceeding. A 50536 dynaring unit is attached close to the proximal clamp with the cushion facing distally, suggesting that it is acting as an extra buttress to the proximal clamp, as it is not dynamising. An 80050 hybrid coupling is attached to the distal end of the rail, and fixed in turn to a sheffield ring. The ring is over the distal tibia and has at least three (visible), and therefore probably 4 wire slider clamps. An anterior radiolucent reinforcing bar runs from the proximal bone screw set to the lateral side of the ring. The antero-medial wire slider unit is broken and held in place by plaster strapping. One wire can be seen protruding from the middle wire hole. Also a very little can be seen of the left leg and it looks short (but this may be a parallax problem). This may be significant as to how much load bearing the left leg has been taking. The soft tissues look to be in good condition with no swelling or scarring. I thought initially that the frame might have been used for bone transport, but there are no signs of screw tracking in the exposed middle part of the leg. In the absence of more information we cannot say anything about the effect of this breakage on the patient. The treatment seems to have been conducted well, although we know very little about what was done. All we know is that the patient felt some pain when the clamp broke, presumably when he was walking. After such a long time on the patient it is not a huge surprise that there was a problem". Final comments a technical evaluation of the device involved was not possible as the device has not been made available. The technical evaluation will be performed as soon as the device becomes available. A complete medical evaluation of the case was not performed as some information about the medical procedure was not made available, i. E. Patient diagnosis, planned treatment, actual duration of the treatment, copies of the operative reports, copies of the pre and post-operative x-rays and the device availability for the technical evaluation. Based on the lack of information available on the event, it was not possible to finalize the investigation and determine the root cause of the event notified. If further information and/or the device involved becomes available, orthofix srl will finalize the investigation. Orthofix srl continues monitoring the devices on the market.
Patient Sequence No: 1, Text Type: N, H10
[39762306]
The information initially provided by the local distributor indicates: product code: 80031 (3-hole wire clamp slider unit) batch number: not provided quantity: (b)(4). Hospital name: (b)(6). Name: not applicable. Date of surgery: not applicable. Body part to which device was applied: distal tibia. Surgery description: fracture treatment patient information: (b)(6) problem observed during: into treatment/post-operative type of problem: device functional problem event description: the patient felt a strong pain in distal tibia then he realized that device was breaking. The screws and wires came away from the external fixator. The complaint report form also indicates: the device failure had adverse effects on patient. An additional surgery was required following device failure (date not available). Copies of the operative reports are not available. Copies of the x-rays are not available. Patient current health condition: patient is in good health conditions. Note and comments: this occurrence has been reported to the national competent authority according to resolution rdc no. 67/09 due this complaint led a serious adverse event as an additional surgery to repair the external fixation system. Anvisa notification/mdr #2015. 11. 000789 notified on 06/nov/2015. On (b)(6) 2015, orthofix srl received the following additional information on the event: batch number of the device involved: not informed. We are going to ask customer again. Date of the initial surgery: (b)(6) 2014. Date of the device breakage: (b)(6) 2015. Patient's age: not available. Date of the second surgery: not informed. We are going to ask customer. Copies of the operative reports (initial and second surgery) and copies of the pre and post-operative x-rays (initial and second surgery): i suppose those files are not available, however i am going to ask the complainant again. Device availability for the technical evaluation: we are trying to provide the device return. As soon as i am able to confirm if this device is available, i will let you know. No other information has been made available over the time. (b)(4)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2015-00073 |
| MDR Report Key | 5260041 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2015-12-02 |
| Date of Report | 2016-03-04 |
| Date of Event | 2015-10-27 |
| Date Mfgr Received | 2016-02-29 |
| Date Added to Maude | 2015-12-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERTO DONADELLO |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer Phone | 0456719000 |
| Manufacturer G1 | ORTHOFIX SRL |
| Manufacturer Street | VIA DELLE NAZIONI, 9 |
| Manufacturer City | BUSSOLENGO, VERONA, ITALY 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 37012 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3-HOLE WIRE CLAMP SLIDER UNIT |
| Generic Name | 3-HOLE WIRE CLAMP SLIDER UNIT |
| Product Code | JEC |
| Date Received | 2015-12-02 |
| Model Number | 80031 |
| Catalog Number | 80031 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | VIA DELLE NAZIONI, 9 BUSSOLENGO, VERONA, ITALY 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-02 |