FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 SAGITTAL SAW
MDR report key: 1935584
·
Received December 14, 2010
Report
- Report Number
- 1811755-2010-02009
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 16, 2010
- Report Date
- November 16, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE E-BOX FAILED DUE TO THE MOTOR FET BEING STUCK WHICH RESULTED IN A SLOW, WEAK RUN ON FOR LESS THAN 3 SECONDS AFTER THE TRIGGER IS RELEASED. THE DEVICE WAS REPAIRED AND RETURNED TO THE SALES REP'S SAMPLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE SALES REP SAMPLE WAS AT THE MFR FOR ROUTINE MAINTENANCE, THE DEVICE RAN WITHOUT BEING ACTIVATED. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 6 SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |