MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-04-08 for K-WIRE 10/10 - LENGTH 70 MM 115070ND manufactured by Integra, Saint Priest.
[16038503]
The reporter stated that a k-wire (kirschner wire) broke during a surgical procedure. The patient's bone was very hard and the drill sheared off the k-wire. Integra has requested additional clinical information.
Patient Sequence No: 1, Text Type: D, B5
[16195047]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2011-00020 |
| MDR Report Key | 2078210 |
| Report Source | 06,07 |
| Date Received | 2011-04-08 |
| Date of Report | 2011-04-08 |
| Date of Event | 2011-03-25 |
| Date Mfgr Received | 2011-03-25 |
| Date Added to Maude | 2011-09-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-WIRE 10/10 - LENGTH 70 MM |
| Generic Name | NA |
| Product Code | DZK |
| Date Received | 2011-04-08 |
| Catalog Number | 115070ND |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, SAINT PRIEST |
| Manufacturer Address | SAINT PRIEST 69800 FR 69800 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-08 |