MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-27 for manufactured by Synthes (usa).
[3472612]
Device report from synthes (b)(6) reports an event in (b)(6) as follows: the kwire broke within the one of the guide holes on the drill template. The kwire was successfully removed from the template using a drill bit. The drill bit broke in the removal process. This is 2 of 3 reports for the same event, complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10864883]
This device is used for treatment, not diagnosis. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn.
Patient Sequence No: 1, Text Type: N, H10
[31593213]
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 | 2520274-2013-03877 |
| MDR Report Key | 3193526 |
| Report Source | 01,07 |
| Date Received | 2013-06-27 |
| Date of Report | 2013-05-28 |
| Date of Event | 2013-05-14 |
| Date Mfgr Received | 2014-10-10 |
| Date Added to Maude | 2013-09-20 |
| 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 | MRS. LINDA PLEWS |
| 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 | 2013-06-27 |
| Returned To Mfg | 2013-06-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-06-27 |