FDA Adverse Event
Malfunction
Summary report: N
REMB SAG SAW
MDR report key: 3132543
·
Received May 29, 2013
Report
- Report Number
- 0001811755-2013-01213
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 15, 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 BALL BEARING ON TOP OF THE ROTOR SHAFT WAS DAMAGED.
Description of Event or Problem · 1
THE REMB SAG SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER IT DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES TO THE USER ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 236328 | REMB SAG SAW | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |