MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-09 for PASSER, WIRE, ORTHOPAEDIC manufactured by Synthes Usa.
[77629653]
There was no known reported patient involvement associated with the complained event. Unknown when device malfunctioned. (510k): this report is for one (1) unknown k-wire. Part and lot numbers are unknown. Without the specific part and lot number, the udi is not available. Device is not implanted/explanted. Without a lot number, the device history record review could not be requested. A product investigation was performed. This complaint is confirmed. The returned insertion guide is missing the set screw component and a broken piece of an unknown k-wire is stuck inside the proximal hole of the insertion guide. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned insertion guide is missing a component and the k-wire is already broken. It cannot be definitively determined that the unknown portion of broken k-wire is a synthes device. However, on (b)(6) 2017 during the investigation of the returned device, it was determined that it most likely is a synthes k-wire based on the fact that synthes k-wires are available in the 3. 5mm lcp proximal humerus plates set that houses this insertion guide. No new malfunctions were identified as a result of the investigation. A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation. A small portion of the broken k-wire is protruding from the inferior side of the plate hole. The k-wire is very deformed (post manufacturing damage) and an accurate measurement of the diameter of the k-wire was unable to be obtained at cq. The set screw component is missing from the insertion guide. A review of the device history records was unable to be performed since the lot number was unknown. A drawing review was unable to be performed since the unknown k-wire part # was unknown. Unable to determine a definitive root cause. Most likely due to removing set screw for sterile processing and misplacing it and forcing a previously malformed/damaged k-wire in the insertion guide hole leading to k-wire breakage and deformation. No new, unique or different patient harms were identified as a result of this evaluation. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[77629654]
It was reported that an insertion guide is missing one set screw and an unknown broken k-wire is stuck in the hole of the insertion guide. The issues were found after sterile processing. There were no reported issues with the insertion guide prior to this discovery. It is unknown if there is a case or patient involvement however, no reported issues during the case the device was last used in. It is unknown how long the insertion guide has been in use. This report is for one (1) unknown k-wire. This is report 1 of 1 for complaint com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-11785 |
| MDR Report Key | 6630182 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-09 |
| Date of Report | 2017-04-11 |
| Date Mfgr Received | 2017-06-06 |
| Date Added to Maude | 2017-06-09 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PASSER, WIRE, ORTHOPAEDIC |
| Product Code | HXI |
| Date Received | 2017-06-09 |
| Returned To Mfg | 2017-04-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-09 |