MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-28 for K-WIRE 10/10 - LENGTH 100 MM * 115100 manufactured by Newdeal S.a..
[514664]
The physician reported that total of three (3) incidents had occurred at the user facility where the 100mm k-wires broke off in the bone. In this inquiry, the physician is referencing only two (2) incidents. The physician recounts that the device splits into two (2) pieces, leaving a piece about 12mm long inside the bone that has to be removed. The physician uses additional instruments to remove the remaining k-wire out of the bone tissue.
Patient Sequence No: 1, Text Type: D, B5
[7832841]
The product return is not expected. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2006-00027 |
| MDR Report Key | 766914 |
| Report Source | 05,06 |
| Date Received | 2006-09-28 |
| Date of Report | 2006-09-26 |
| Date Mfgr Received | 2006-09-04 |
| Date Added to Maude | 2006-10-06 |
| 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 | DANIEL-GARY 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 100 MM |
| Generic Name | K-WIRE |
| Product Code | DZK |
| Date Received | 2006-09-28 |
| Model Number | * |
| Catalog Number | 115100 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 754812 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-28 |