FDA Adverse Event
Malfunction
Summary report: N
K-WIRE CUTTING PLIERS (MAX 1.6MM)
MDR report key: 2002441
·
Received January 28, 2011
Report
- Report Number
- 8010177-2011-00025
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 7, 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
- FI
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.
Description of Event or Problem · 1
THE NURSE INFORMED THE SALES REP THAT THE SCREW OF THE INSTRUMENT GOT BROKEN DURING THE OPERATION. OPERATION WENT OK. THERE IS NO LOT NUMBER ON THE INSTRUMENT.
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 | Z9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |