FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE SAG SAW
MDR report key: 1935138
·
Received December 6, 2010
Report
- Report Number
- 1811755-2010-01916
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 8, 2010
- Report Date
- November 8, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE SAGITTAL HEAD WAS CORRODED AND THE SPACER WASHER WAS WORN. THE BEARINGS, FRONT HOUSING, ALONG WITH OTHER COMPONENTS, WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING ROUTINE PREVENTATIVE MAINTENANCE TESTING BY THE MANUFACTURER. THIS DID NOT OCCUR DURING ANY SURGICAL OR MEDICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE SAG SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |