MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-16 for PINS/WIRES manufactured by Synthes Usa.
[3090231]
Surgeon reported that the 1. 8mm wires are occasionally slipping along the wire bolt-offset. It is reported the wires have not broken and work as designed. This report is #2 of 2 for this event.
Patient Sequence No: 1, Text Type: D, B5
[10234526]
Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. Manufacturing records could not be reviewed without a lot number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-02282 |
| MDR Report Key | 2799454 |
| Report Source | 05,07 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-09-17 |
| Date Mfgr Received | 2012-09-17 |
| Date Added to Maude | 2013-01-30 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODI TEMPLE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINS/WIRES |
| Generic Name | PINS/WIRES |
| Product Code | DZK |
| Date Received | 2012-10-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-16 |