FDA Adverse Event
Malfunction
Summary report: N
K-WIRE CUTTING PLIERS (MAX 1.6MM)
MDR report key: 2191435
·
Received July 27, 2011
Report
- Report Number
- 8010177-2011-00212
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- July 4, 2011
- Report Date
- July 4, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS FREIBURG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CRACK SHOWS AN INTER-CRYSTALLINE FORCED RUPTURE MODE DUE TO STRESS CRACK CORROSION. THE CRACK OCCURRED DUE TO VERY HIGH COMPRESSIVE FORCES OF THE RETAINING SCREW. THE ROOT CAUSE CAN BE ATTRIBUTED TO A MFG RELATED ISSUE OF TOO HIGH TIGHTENING FORCES APPLIED TO THE SPRING'S RETAINING THE SCREW.
Description of Event or Problem · 1
CRACKS AT INNER SIDE OF THE GRIP PARTS WERE FOUND UPON INSPECTION OF THE RETURNED LONER KIT FROM THE HOSP. THERE WAS NO REPORT FROM THE HOSP ON THIS ISSUE. THEREFORE, THERE IS NO INFO AS TO HOWE THESE CRACKS WERE FORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | K-WIRE CUTTING PLIERS (MAX 1.6MM) | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS FREIBURG | NA | AB05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |