FDA Adverse Event
Malfunction
Summary report: N
ADJ PIN COLLET 2.0-3.2MM
MDR report key: 2140372
·
Received June 17, 2011
Report
- Report Number
- 1811755-2011-02212
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 26, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MFR FOR INVESTIGATION. WHEN THE DEVICE IS RECEIVED, A QUALITY INVESTIGATION WILL BE PERFORMED AND A F/U REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT METAL SHAVINGS CAME OUT OF THE DEVICE DURING CLEANING. 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 | ADJ PIN COLLET 2.0-3.2MM | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |