MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-09-28 for PINS/WIRES manufactured by Synthes (usa).
[3036109]
During a procedure the surgeon noticed that the liss insertion guide did not align the guide wire in the holes of the df plate. This report is #2 of 2 for the same event.
Patient Sequence No: 1, Text Type: D, B5
[10213985]
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 | 2520274-2012-02043 |
| MDR Report Key | 2776699 |
| Report Source | 01,07 |
| Date Received | 2012-09-28 |
| Date of Report | 2012-08-30 |
| Date Mfgr Received | 2012-08-30 |
| Date Added to Maude | 2013-01-16 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 |
| Manufacturer G1 | SYNTHES (USA) |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| 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 | 2012-09-28 |
| 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 | 2012-09-28 |