MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-08-27 for GOTFRIED PC.C.P. NECK SECOND SLEEVE 197000 manufactured by Orthofix Srl.
[118265017]
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the (b)(4) batch 01088094 before the market release. No anomalies have been found. The original lot, manufactured in 2016, was comprised of 25 devices. All of them have already been distributed to the market. According to orthofix srl historical records, this is the second complaint notified in regards to this specific device lot. Both events occurred at the same hospital with the same surgeon. Technical evaluation: the device concerned has not yet been received by orthofix srl. The technical evaluation will be performed as soon as the device is received. Medical evaluation: the information made available on the case was sent to our medical evaluator. A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation and/or further information on the case are available. Orthofix srl has requested the distributor to provide further information on the event such as date of surgery, patient details and patient current health condition. As soon as further information and/or the results of the technical evaluation are 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
[118265018]
On august 2, 2018, orthofix srl received an email from the (b)(4) distributor who complained about a (b)(4) stating that they have two devices with the same code which feature different characteristics (total length and threads). This difference, in regards to the complained device, leads to sticking of drill bit during surgery. This problem delayed the surgery almost 30 minutes and at the end they had to change the system to a richard plate. On august 23, 2018, orthofix srl received the completed complaint form which included the following details: device code: (b)(4); batch number: 01088094; quantity: 1; hospital name: (b)(6); surgeon's name: (b)(6); date of surgery: no response; body part to which device was applied: hips; surgery description: fracture treatment; patient information: no response; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: "during the placement of the neck screw at the time of introducing the 7mm drill bit in guide no. 2, the surgeon presents great difficulty in passing the drill bit. This delays the surgery almost 30 minutes". The complaint report form also indicates: the device failure did not have any adverse effects on patient; the initial surgery was completed with the device; the event led to a clinically relevant increase in the duration of the surgical procedure (delay of 30 minutes); an additional surgery was not required; a medical intervention (outpatient clinic) was not required copies of the operative reports are not available; copies of the x-ray images are not available; patient current health condition: no response. Manufacturer reference number: (b)(4). Distributor reference number: email of august 2, 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680825-2018-00076 |
| MDR Report Key | 7817559 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-08-27 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2018-08-27 |
| Device Manufacturer Date | 2016-11-23 |
| Date Added to Maude | 2018-08-27 |
| 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, 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 | GOTFRIED PC.C.P. NECK SECOND SLEEVE |
| Generic Name | GOTFRIED PC.C.P. NECK SECOND SLEEVE |
| Product Code | JDO |
| Date Received | 2018-08-27 |
| Returned To Mfg | 2018-08-25 |
| Model Number | 197000 |
| Catalog Number | 197000 |
| Lot Number | 01088094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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, 37012 IT 37012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-27 |