MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-11-08 for CEMENT REMOVAL HANDSET OH300/2 manufactured by Orthofix Srl.
[126510904]
On july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision. Therefore, orthofix (b)(4) is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd. The devices involved in this event were manufactured by orthosonics ltd. Technical evaluation: the returned devices, received on september 13th, 2018, were examined by orthofix (b)(4) quality engineering department. All devices were subjected to visual and functional check as per orthofix (b)(4) specification. The visual check evidenced as follows: the ultrasonic generator, device code os3000 serial number (b)(4), did not show any anomalies. For all the three cement removal handsets, devices code oh300/2, the shroud is missing. Moreover, one cement removal handset, device code oh300/2 batch 3h0082, is missing also the rear end cap o-ring. The functional check evidenced as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly. The cement removal handset, device code oh300/2 batch 3h0078, is not functioning properly. The sealing is lost from the front flange, therefore the handset does not work. The generator shows the alert message: "poor feedback, release all switches". The cement removal handset, device code oh300/02 batch 3h0080, is not functioning properly. The ceramics inside are broken. The handset does not work. The generator shows alert message: "poor feedback". The cement removal handset, device code oh300/2 batch 3h0082, is not functioning properly. The sealing is lost from the rear body seal, therefore the handset does not work. The handset is not detected by the generator. The results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly (mfr report 9680825-2018-00084). The failure found on the cement removal handset, device code oh300/2 batch 3h0078, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles. This may happen as a result of normal wear and tear of silicone o-rings (mfr report 9680825-2018-00094). 3). The failure found on the cement removal handset, device code oh300/2 batch 3h0080, is most likely attributable to a normal wear and tear of the internal ceramics (this report). 4). The failure found on the cement removal handset, device code oh300/2 batch 3h0082, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles. This may happen as a result of the absence of silicone o-rings and is attributable to an incorrect handling of the device (mfr report 9680825-2018-00096). Medical evaluation: the information made available on the case together with the results of the technical investigation were sent to our medical evaluator. Please find below an extract of the medical evaluations performed. "in this case a male patient had an accident that resulted in the fracture of a hip implant (not specified). The implant was in the femur and must have been cemented in place, because the oscar system was required to remove the cement to allow for a replacement implant. There appears to have been an electrical problem with the oscar system which failed to function. As a result the surgeon had no option but to continue with the operation with hand tools. In order to remove the cement it was necessary to do an osteotomy in the femur for access. Because of the nature of the osteotomy it was necessary for the patient to be non weightbearing for 6 weeks, as he is elderly and quite heavy. In practice it was necessary for the patient to remain in hospital for 6 weeks as he could not be cared for elsewhere". Final comments: on july 2017 orthofix (b)(4) acquired from orthosonics ltd, the oscar system, for ultrasonic arthroplasty revision. Therefore, orthofix (b)(4) is now managing post-market surveillance for oscar devices, also for the ones manufactured and released to the market by orthosonics ltd. The devices involved in this event were manufactured by orthosonics ltd. The results of the technical evaluation concluded as follows: the ultrasonic generator, device code os3000 serial number (b)(4) is functioning properly (mfr report 9680825-2018-00084). The failure found on the cement removal handset, device code oh300/2 batch 3h0078, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles. This may happen as a result of normal wear and tear of silicone o-rings (mfr report 9680825-2018-00094). The failure found on the cement removal handset, device code oh300/2 batch 3h0080, is most likely attributable to a normal wear and tear of the internal ceramics (this report). 4). The failure found on the cement removal handset, device code oh300/2 batch 3h0082, is most likely attributable to water that entered inside the handset during cleaning and sterilization cycles. This may happen as a result of the absence of silicone o-rings and is attributable to an incorrect handling of the device (mfr report 9680825-2018-00096). The medical evaluation evidenced as follows: "in this case a male patient had an accident that resulted in the fracture of a hip implant (not specified). The implant was in the femur and must have been cemented in place, because the oscar system was required to remove the cement to allow for a replacement implant. There appears to have been an electrical problem with the oscar system which failed to function. As a result the surgeon had no option but to continue with the operation with hand tools. In order to remove the cement it was necessary to do an osteotomy in the femur for access. Because of the nature of the osteotomy it was necessary for the patient to be non weightbearing for 6 weeks, as he is elderly and quite heavy. In practice it was necessary for the patient to remain in hospital for 6 weeks as he could not be cared for elsewhere". Based on the results of the technical evaluation, which confirmed the ultrasonic generator conformity, an on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is due to normal wear and tear of the handsets. Orthofix (b)(4) continues monitoring the devices on the market.
Patient Sequence No: 1, Text Type: N, H10
[126510905]
The information provided by the local distributor indicates: hospital name: (b)(6). Surgeon name: mr (b)(6). Date of surgery: (b)(6) 2018. Body part to which device was applied: no response. Surgery description: fracture treatment/other. Patient information: male. Problem observed during: clinical use on patient/intraoperative. Type of problem: device functional problem. Event description: "surgery was for implant fracture. Electrical arcing was seen and heard by the surgeon in the oscar control box. The handpiece was feeling warm and would not work. The malfunction of the oscar until led to an extended operative time for the case with increased bloodloss. An osteotomy was performed to assist with cement clearance which unfortunately extended and requiring wiring". The complaint report form also indicates: the device failure caused adverse effects to patient. The initial surgery was not completed with the device. A replacement device was immediately available to complete the surgery. The event led to a clinically relevant increase in the duration of the surgical procedure. An additional surgery was not required. A medical intervention (outpatient clinic) was not required. Copies of the operative report are not available. Copies of the x-ray images are not available. Patient current health conditions: "the result of this is a 6 week period of non weight bearing which at this patient age and weight is essentially 6 weeks in hospital". On september 25th, 2018, orthofix received the following communication "the patient was a trauma patient and it is not possible to get the patient weight and height. We will try again and see if it is possible to get the copy of the patient x-rays". No other information was provided. Manufacturer reference number: (b)(4). Distributor reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2018-00095 |
| MDR Report Key | 8050025 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-11-08 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-11-08 |
| 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 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 | CEMENT REMOVAL HANDSET |
| Generic Name | CEMENT REMOVAL HANDSET |
| Product Code | JDX |
| Date Received | 2018-11-08 |
| Returned To Mfg | 2018-09-13 |
| Model Number | OH300/2 |
| Catalog Number | OH300/2 |
| Lot Number | 3H0080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-08 |