FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 3143338
·
Received June 3, 2013
Report
- Report Number
- 0001811755-2013-01288
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 7, 2013
- Report Date
- May 7, 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
WIDESPREAD CORROSION AND DAMAGE WAS DISCOVERED UPON DISASSEMBLY.
Description of Event or Problem · 1
THE MICRO SAGITTAL SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT WAS FOUND TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244711 | MICRO SAGITTAL SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |