FDA Adverse Event
Malfunction
Summary report: N
WIRE COLLET
MDR report key: 2140437
·
Received June 17, 2011
Report
- Report Number
- 1811755-2011-02214
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 25, 2011
- Report Date
- June 1, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE WERE METAL CHIPS STUCK BETWEEN THE WEDGE COLLET AND SMALL COLLET. 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 WIRE WAS STICKING IN THE DEVICE. 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 | WIRE COLLET | KIJ | STRYKER INSTRUMENTS KALAMAZOO | 11048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |