FDA Adverse Event
Malfunction
Summary report: N
SGL TRIG PIN COLLET 3.0-4.2MM
MDR report key: 2223252
·
Received August 16, 2011
Report
- Report Number
- 1811755-2011-02997
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 20, 2011
- Report Date
- July 27, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- 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 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 THE RELEASE THE PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS NOT FUNCTIONING 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 | SGL TRIG PIN COLLET 3.0-4.2MM | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |