FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 1960733
·
Received December 16, 2010
Report
- Report Number
- 1811755-2010-02052
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- November 23, 2010
- Report Date
- November 24, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS CORROSION ON THE ROTOR, AS WELL AS, PROBLEMS WITH THE MOTOR, SAG HEAD, AND BEARINGS. THOSE PARTS WERE REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE WAS READING AS OVERHEATING ON THE CONSOLE WHILE BEING TESTED. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |