MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-04-26 for UNI-CLIP DRILL GUIDE * 119301 manufactured by Newdeal S.a..
[389603]
The handle broke during the procedure. However, device could still be used and the surgeon used it to complete the surgery. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615741-2005-00008 |
| MDR Report Key | 596684 |
| Report Source | 08 |
| Date Received | 2005-04-26 |
| Date of Report | 2005-04-26 |
| Date Mfgr Received | 2005-03-29 |
| Date Added to Maude | 2005-04-29 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | YANPING WANG |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362322 |
| Manufacturer G1 | NEWDEAL S.A. |
| Manufacturer Street | 10, PLACE D'HELVETIE |
| Manufacturer City | LYON 69006 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNI-CLIP DRILL GUIDE |
| Generic Name | UNI-CLIP IMPLANT ASSOCIATED INSTRUMENT |
| Product Code | HXY |
| Date Received | 2005-04-26 |
| Model Number | * |
| Catalog Number | 119301 |
| Lot Number | CF |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 586501 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Baseline Brand Name | UNI-CLIP DRILL GUIDE |
| Baseline Generic Name | UNI-CLIP IMPLANT ASSOCIATED INSTRUMENT |
| Baseline Model No | * |
| Baseline Catalog No | 119301 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-26 |