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 2017-09-12 for WASHER, BOLT, NUT, NON-SPINAL, CETALLIC manufactured by Synthes Usa.
[85910309]
This report is for unknown washer /unknown lot number. Device is not expected to be returned for manufacturer review/investigation. Devices were removed intact on (b)(6) 2017 due to infection. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[85910310]
It was reported that one tibial nail with an unknown quantity of proximal locking screws, one lcp plate with an unknown quantity of cortical and locking screws, and one 6. 5mm or 7. 3mm cannulated screw with washer (independent of the lcp plate) were removed intact on (b)(6) 2017 due to infection. There were no reported issues with the hardware. The devices were originally implanted on an unknown date by another surgeon for an ankle fracture. The surgery was successfully completed with good patient outcome. The surgeon plans to fuse the patient? S ankle when the infection clears up. This complaint involves 1 nail, 1 plate, 1 washer and an unknown number of screws. This report is 7 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12257 |
| MDR Report Key | 6860184 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-12 |
| Date of Report | 2017-08-21 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-09-12 |
| 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 | WASHER, BOLT, NUT, NON-SPINAL, CETALLIC |
| Product Code | NDG |
| Date Received | 2017-09-12 |
| 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 | 1. Required No Informationntervention | 2017-09-12 |