MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2007-12-14 for K-WIRE 10/10 LENGTH 70 MM 115070 115070ND manufactured by Newdeal S.a..
[768960]
The integra sales representative ("representative') reported on behalf of the user facility the following incident: the physician had to perform a revision surgery on a patient to remove a broken device. The device was between the metatarsal and the skin. The original surgery was an insertion of a bold screw. The physician had missed the piece of the device on the post operative x-ray. The user facility is conducting an internal investigation, and the device is not available for return. According to the representative, the physician discussed the procedure, and the physician seemed to follow the surgical technique guide.
Patient Sequence No: 1, Text Type: D, B5
[8037113]
The device is not expected to be returned for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2007-00076 |
| MDR Report Key | 964284 |
| Report Source | 05,06,07 |
| Date Received | 2007-12-14 |
| Date of Report | 2007-12-14 |
| Date Mfgr Received | 2007-11-15 |
| Date Added to Maude | 2007-12-19 |
| 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 | DANIEL HOLDERMAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362469 |
| 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 | K-WIRE 10/10 LENGTH 70 MM |
| Generic Name | K-WIRE |
| Product Code | DZK |
| Date Received | 2007-12-14 |
| Model Number | 115070 |
| Catalog Number | 115070ND |
| Lot Number | E3QY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 935771 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-14 |