FDA Adverse Event
Malfunction
Summary report: N
R/R MICRODRILL STRAIGHT ATT
MDR report key: 1935137
·
Received December 6, 2010
Report
- Report Number
- 1811755-2010-01918
- 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 TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.
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 | R/R MICRODRILL STRAIGHT ATT | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO | 07285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |