FDA Adverse Event
Malfunction
Summary report: N
R/R SINGLE TRIG PIN COLLET
MDR report key: 1983785
·
Received January 11, 2011
Report
- Report Number
- 1811755-2011-00064
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- 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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF. THIS CONDITION COULD CAUSE THE DEVICE TO STICK, AND NOT ALLOW THE COLLET TO RELEASE THE WIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PINS WERE STICKING IN THE COLLET DURING TESTING IN HOUSE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R/R SINGLE TRIG PIN COLLET | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |