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 2016-05-19 for SHARP HOOK 319.39 manufactured by Synthes Usa.
[45576869]
(b)(4). Device is an instrument and is not implanted/explanted. Complainant part is not expected to be returned for manufacturer review/investigation as it has been reportedly discarded by the facility. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[45576870]
It was reported that during a procedure to repair an ankle fracture, the tip of the sharp hook broke while reducing the fracture. The broken tip fell outside of the patient and the surgeon was able to retrieve the broken tip. The surgeon used another instrument to complete the procedure. There was a two minute surgical delay. No additional medical intervention required. Standard x-rays were taken unrelated to the breakage of the sharp hook. The procedure was completed successfully. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-12765 |
| MDR Report Key | 5667288 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-05-05 |
| Date Added to Maude | 2016-05-19 |
| 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 | TERRY CALLAHAN |
| 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 |
| Brand Name | SHARP HOOK |
| Generic Name | HOOK, SURGICAL, GEN & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2016-05-19 |
| Catalog Number | 319.39 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-05-19 |