MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-05-07 for K-WIRE BENDING PLIERS 64-20118 manufactured by Stryker Osteosynthesis Freiburg.
[18237807]
It was reported that, "part of the instrument that allows it to bend and cut the wire broke off so it can no longer function correctly. Found before the surgery so never entered into surgery".
Patient Sequence No: 1, Text Type: D, B5
[18360558]
Device analysis in process but not yet complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010177-2010-00209 |
| MDR Report Key | 1693452 |
| Report Source | 07 |
| Date Received | 2010-05-07 |
| Date of Report | 2010-04-16 |
| Date of Event | 2010-04-16 |
| Date Mfgr Received | 2010-04-16 |
| Date Added to Maude | 2011-02-02 |
| 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 | SHAWN KLOHA |
| Manufacturer Street | 750 TRADE CENTRE WAY SUITE 200 |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693245346 |
| Manufacturer G1 | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Street | BOTZINGER STRASSE 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-WIRE BENDING PLIERS |
| Generic Name | INSTRUMENT |
| Product Code | EJY |
| Date Received | 2010-05-07 |
| Returned To Mfg | 2010-05-05 |
| Model Number | NA |
| Catalog Number | 64-20118 |
| Lot Number | U8-08/04 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER OSTEOSYNTHESIS FREIBURG |
| Manufacturer Address | FREIBURG D-79111 GM D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-07 |