FDA Adverse Event
Malfunction
Summary report: N
K-WIRE CUTTING PLIERS (MAX 1.6MM)
MDR report key: 2002565
·
Received January 28, 2011
Report
- Report Number
- 8010177-2011-00023
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- January 3, 2011
- Report Date
- January 5, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "METAL PIECE THAT IS CONNECTED TO ONE OF THE GUIDES FELL OFF. IT IS NO LONGER ABLE TO CUT, THE PLIERS DON'T COME TOGETHER PROPERLY." ADDITIONAL INFORMATION RECEIVED FROM SALES REP ON 01/28, INDICATES THAT THE TIP OF THE PLIERS BROKE OFF.
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 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |