MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-05 for manufactured by Synthes Usa.
[4147546]
During surgery for a radial shortening, the surgeon was drilling a second 2. 5mm wire through the small distractor on the external fixator and the 2. 5mm wire jammed in the threaded hole. The second wire never made it into the patient? S bone; it jammed into the distractor. The distractor was pulled off the first 2. 5mm wire and away from the patient. The second wire could not be removed. The second wire was cut and the distractor was re-applied over the first wire. Surgeon then completed the surgery by placing a 1. 6mm wire into a different hole. Surgery continued without further incident and necessary compression was achieved. Due to this event an additional 15-30 minutes was added to operating room time. This report is for an unknown part. This report is 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11398372]
Device is an instrument and is not implanted or explanted subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. Without a lot number the device history records review could not be completed. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07608 |
| MDR Report Key | 3501782 |
| Report Source | 05,07 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-10-29 |
| Date of Event | 2013-10-29 |
| Date Mfgr Received | 2013-10-29 |
| Date Added to Maude | 2014-03-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH TASCIONE |
| 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 |
| Product Code | DZK |
| Date Received | 2013-12-05 |
| Returned To Mfg | 2013-11-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-05 |