FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE SAG SAW
MDR report key: 1942296
·
Received December 22, 2010
Report
- Report Number
- 1811755-2010-02100
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 15, 2010
- Report Date
- November 16, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED. ACCORDING TO THE INVESTIGATION DETAILS, THE ROTOR BEARINGS WERE GRITTY AND THE UPPER BEARINGS WERE WORN, WHICH WERE BOTH REPLACED, ALONG WITH OTHER COMPONENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING ROUTINE MAINTENANCE TESTING BY THE MANUFACTURER AT THE ACCOUNT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. 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/ATTACHM | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |