FDA Adverse Event
Malfunction
Summary report: N
K-WIRE COCR, RECON 73.2X400 MM
MDR report key: 1071833
·
Received July 8, 2008
Report
- Report Number
- 9610622-2008-00106
- Event Type
- Malfunction
- Date Received
- July 8, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 13, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS DISCARDED BY THE HOSPITAL. NO EVAL WILL BE PERFORMED. IF ADD'L INFO IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "AFTER INSERTING THE NAIL, SURGEON CONNECTED THE RECON MODE TARGETING ARM, PUT IN DRILL SLEEVE THROUGH SOFT TISSUE, AND THEN BEGAN TO INSERT THE K-WIRES. AT THIS POINT THE K-WIRES WOULD NOT THREAD THROUGH THE NAIL, THEN REMOVED THE K-WIRE, AND THE THREADED PART HAD BROKEN OFF INSIDE THE NAIL, SO REMOVED THE DRILL SLEEVE, AND REMOVED THE NAIL TO GET OUT THE BROKEN PIECE. THEN TRIED TO REPEAT PROCESS AND THE SAME THING HAPPENED WITH A DIFFERENT K-WIRE. AFTER THE SECOND WIRE BROKE, DECIDED TO USE THE ANTEGRADE MODE FOR PROXIMAL LOCKING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-WIRE COCR, RECON 73.2X400 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |