FDA Adverse Event
Malfunction
Summary report: N
APJ PIN COLLET 2.0-3.2MM
MDR report key: 2229015
·
Received August 22, 2011
Report
- Report Number
- 1811755-2011-03092
- Event Type
- Malfunction
- Date Received
- August 22, 2011
- Date of Event
- July 23, 2011
- Report Date
- July 23, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR EVALUATED THE DEVICE AND UPON DISASSEMBLY THE IMPREGLON COATING WORN OFF THE COLLET. IMPREGLON COATING WEAR DEBRIS WILL CAUSE THE COLLET LEVER TO STICK AND NOT RELEASE AN INSERTED WIRE OR PIN. THE DEVICE IS NOT REPAIRABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SMALL PIN GETS STUCK IN THE COLLET DUE TO THE IMPREGLON COATING ON THE COLLET BEING WORN OFF. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APJ PIN COLLET 2.0-3.2MM | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |