FDA Adverse Event
Malfunction
Summary report: N
K-WIRE, RECON ?3.2X400 MM
MDR report key: 1297382
·
Received November 21, 2008
Report
- Report Number
- 9610622-2008-00247
- Event Type
- Malfunction
- Date Received
- November 21, 2008
- Date of Event
- October 27, 2008
- Report Date
- October 27, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, DURING T2 RECON NAIL SURGERY, THE SURGEON TRIED TO INSERT THE K-WIRE ABOUT FIVE TIMES TO CHANGE THE POSITION OF K-WIRE. THE TIP OF K-WIRE BROKE INSIDE THE FEMORAL BONE. THE SURGEON REMOVED THE TIP OF IT. THE SURGEON USED A NEW K-WIRE AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-WIRE, RECON ?3.2X400 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | K893290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |