FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
MDR report key: 2891095
·
Received November 14, 2012
Report
- Report Number
- 1811755-2012-04063
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 16, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE CONDUCTED AT THE MANUFACTURER FACILITY, THE LEAFKEY HOUSING OF THE HANDPIECE WAS CHIPPING. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AT THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |