FDA Adverse Event
Malfunction
Summary report: N
ADJUSTABLE PIN COLLET
MDR report key: 2150304
·
Received June 7, 2011
Report
- Report Number
- 1811755-2011-02036
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Date of Event
- May 9, 2011
- Report Date
- May 12, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- UNKNOWN
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 PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PINS WERE STICKING IN THE DEVICE DURING A PROCEDURE. THE ACCOUNT HAD A BACK UP ON HAND TO COMPLETE THE CASE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.
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 |