MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-12-21 for UNI-CLIP DRILL GUIDE manufactured by Newdeal S.a..
[15863261]
The reporter stated that during a forefoot surgical procedure to introduce a uni clip compression plate, the drill guide snapped and broke making it unsuitable for continued use. The hospital had another instrument set which was opened to complete the surgery. There was no adverse outcome for the pt.
Patient Sequence No: 1, Text Type: D, B5
[15869348]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2011-00072 |
| MDR Report Key | 2419022 |
| Report Source | 01,05 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-12-21 |
| Date of Event | 2011-11-28 |
| Date Mfgr Received | 2011-11-28 |
| Date Added to Maude | 2012-07-25 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNI-CLIP DRILL GUIDE |
| Generic Name | UNI-CLIP |
| Product Code | HXY |
| Date Received | 2011-12-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | SAINT PRIEST FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-21 |