FDA Adverse Event
Malfunction
Summary report: N
K-WIRE CUTTING PLIERS (MAX 1.6MM)
MDR report key: 2191929
·
Received July 22, 2011
Report
- Report Number
- 8010177-2011-00206
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 30, 2011
- Report Date
- June 30, 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
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
CRACKS AT THE INNER SIDE OF THE GRIP PARTS WERE FOUND DURING 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 HOW 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 | AA10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |