MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-09-16 for manufactured by Synthes Usa.
[15773694]
The risk management coordinator reported an explant on (b)(6) 2013. The patient reported pain in the left ankle. The surgeon performed an left ankle arthroscopy debridement and hardware removal. During the procedure the hollow reamer broke in half during removal. The hollow reamer was retrieved and no fragments were left in the patient. There was no harm caused to the patient. Along with the reamer two screws one syndesmotic and one unidentified washer was also removed during the procedure. This report is for an unknown washer. This is report 2 of 4 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15974768]
Device was used for treatment, not diagnosis. 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 | 2520274-2013-01184 |
| MDR Report Key | 3349141 |
| Report Source | 06,07 |
| Date Received | 2013-09-16 |
| Date of Report | 2013-02-06 |
| Date of Event | 2013-01-04 |
| Date Mfgr Received | 2013-02-06 |
| Date Added to Maude | 2013-09-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICOLE GAMBLE |
| 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 | NDG |
| Date Received | 2013-09-16 |
| 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 | 2013-09-16 |