FDA Adverse Event
Malfunction
Summary report: N
REMB SAG SAW
MDR report key: 2990779
·
Received March 5, 2013
Report
- Report Number
- 0001811755-2013-00451
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 18, 2013
- Report Date
- February 18, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING THE DEVICE EVALUATION, THE MOTOR ASSEMBLY INCLUDING THE PRINTED CIRCUIT BOARD (TPS FLEX ASSEMBLY) WERE FOUND TO BE CORRODED. THE PRESENCE OF CORROSION WAS IDENTIFIED AS A PROBABLE CAUSE OF THE REPORTED BIAS CURRENT ERROR, AS CORROSION CAN INTERFERE WITH THE DEVICE'S ELECTRICAL CURRENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE SAW CAUSED A BIAS CURRENT WARNING TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93631 | REMB SAG SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |