FDA Adverse Event
Malfunction
Summary report: N
ADJUSTABLE PIN COLLET
MDR report key: 2140426
·
Received June 17, 2011
Report
- Report Number
- 1811755-2011-02228
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 8, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR 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 PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PIN WAS STICKING IN THE DEVICE DURING TESTING. 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 | ADJUSTABLE PIN COLLET | GET | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |