FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 3240225
·
Received July 22, 2013
Report
- Report Number
- 0001811755-2013-01746
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Date of Event
- July 11, 2013
- Report Date
- July 11, 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
UPON DISASSEMBLY FOR VISUAL INSPECTION, THE BUTTON IS PUSHED IN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MICRO SAGITTAL SAW WAS BEING TESTED AT THE MANUFACTURER¿S FACILITY WHEN THE BLADE WHIPPED AND BROKE A BLADE. THERE WAS NO PATIENT OR USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339406 | MICRO SAGITTAL SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN BLADE |