FDA Adverse Event
Malfunction
Summary report: N
REMB SAG SAW
MDR report key: 2982707
·
Received February 28, 2013
Report
- Report Number
- 0001811755-2013-00397
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 1, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING THE DEVICE EVALUATION, CORRODED SOCKETS, A CORRODED MOTOR AND A DAMAGED PC BOARD (FLEX ASSEMBLY) WERE FOUND, WHICH ARE PROBABLE CAUSES OF THE DEVICE RUNNING WITHOUT USER ACTIVATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE DEVICE WAS RUNNING 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 |
|---|---|---|---|---|---|---|---|
| 88279 | REMB SAG SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |