FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 3041396
·
Received April 8, 2013
Report
- Report Number
- 0001811755-2013-00725
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 12, 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 EVALUATION IT WAS DISCOVERED THAT MULTIPLE INTERNAL COMPONENTS WERE BROKEN/DAMAGED INCLUDING THE NOSE HOUSING, FRONT HOUSING, YOKE, AND LINK WITH FINS. IN ADDITION, THERE WAS CORROSION IN THE PRESS PLUG.
Description of Event or Problem · 1
THE MICRO SAGGITAL SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE SIGNALING A CONDITION OCCURED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143155 | MICRO SAGITTAL SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |