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 2007-02-08 for K-WIRE 10/10, 100 MM, ONE THREADED, ONE BLUNT * 115110 manufactured by Newdeal S.a..
[590325]
The integra sales representative reported the following incident on behalf of the user facility: the threaded tip of the device broke off at the point where the threaded portion meets the non-threaded portion of the shaft. The physician was able to retrieve the broken piece of the device from the patient. This incident is related to mdr 9615741-2007-00006.
Patient Sequence No: 1, Text Type: D, B5
[7945153]
The product is not expected to be return. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2007-00005 |
| MDR Report Key | 819045 |
| Report Source | 05,06,07 |
| Date Received | 2007-02-08 |
| Date of Report | 2007-02-05 |
| Date of Event | 2007-01-02 |
| Date Mfgr Received | 2007-01-08 |
| Date Added to Maude | 2007-02-22 |
| 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, 100 MM, ONE THREADED, ONE BLUNT |
| Generic Name | K-WIRE |
| Product Code | DZK |
| Date Received | 2007-02-08 |
| Model Number | * |
| Catalog Number | 115110 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 806531 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Baseline Brand Name | K-WIRE 10/10, 100 MM, ONE THREADED, ONE BLUNT |
| Baseline Generic Name | K-WIRE |
| Baseline Model No | * |
| Baseline Catalog No | 115110 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-02-08 |