MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-22 for SHARP HOOK 319.39 manufactured by Synthes Usa.
[36751836]
(b)(4). Device is an instrument and is not implanted or explanted. Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Without a lot number, the device history record review could not be requested. Device 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
[36751837]
It was reported that the tip of a sharp hook broke off during an open reduction and internal fixation (orif) procedure of a scapula fracture on (b)(6) 2016. The surgeon was manipulating a bone fragment into place when the tip broke off. The fragment was retrieved and no surgical delay occurred due to the breakage. Back-up instruments were immediately available to complete the procedure. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[39250522]
Device was used for treatment, not diagnosis. A product investigation was completed: one sharp hook (product code: 319. 39, lot number/mfg date: unknown). The instrument was received with the distal tip being broken off and was not returned. The received condition is consistent with the result of excessive force. Thus, although the root cause cannot be definitively determined, it is probable that the method of use and/or handling resulted in the complaint condition. Drawings for the device were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. No device history record review can be done for the returned instrument because the lot number is unknown. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. 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
| Report Number | 2520274-2016-10412 |
| MDR Report Key | 5386475 |
| Date Received | 2016-01-22 |
| Date of Report | 2016-01-08 |
| Date of Event | 2016-01-08 |
| Date Mfgr Received | 2016-02-22 |
| Date Added to Maude | 2016-01-22 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES USA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARP HOOK |
| Generic Name | HOOK, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2016-01-22 |
| Returned To Mfg | 2016-01-19 |
| Catalog Number | 319.39 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-01-22 |