MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-12-13 for PINS/WIRES manufactured by Synthes Usa.
[3180975]
Surgeon inserted screw in the medial malleolus using a 1. 6 mm trocar and placed 2 guide wires in patient. Surgeon measured and used a 3. 2 drill bit; when the drill bit was removed, the 1. 6 guide wire came out in the drill bit. The surgeon had to drill another hole and the tech attempted to remove the guide wire out of the drill bit so that it could be re used. She tried both a needle driver and pliers unsuccessfully. She used the trocar to try to push it out and stuck herself with it in the pinkie finger. She broke scrub and followed facility protocol for her injury. The physician used another drill bit in the set to complete the procedure. This is 3 of 3 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[10286908]
Device used for treatment and not diagnosis. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-03937 |
| MDR Report Key | 2872423 |
| Report Source | 05,07 |
| Date Received | 2012-12-13 |
| Date of Report | 2012-11-15 |
| Date of Event | 2012-11-15 |
| Date Mfgr Received | 2012-11-15 |
| Date Added to Maude | 2012-12-13 |
| 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 | SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PINS/WIRES |
| Product Code | DZK |
| Date Received | 2012-12-13 |
| 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 | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-13 |