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 |