FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 3
MDR report key: 1935580
·
Received December 14, 2010
Report
- Report Number
- 1811755-2010-02022
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 18, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN REC'D AT THE MFR FOR TESTING. AN EVAL 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 MAINTENANCE TESTING BY THE MFR. THIS DID NOT OCCUR DURING ANY SURGICAL OR MEDICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 3 | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |