FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE RECIP SAW
MDR report key: 1935149
·
Received December 6, 2010
Report
- Report Number
- 1811755-2010-01919
- 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
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION. THE REPORTED CONDITION COULD NOT BE CONFIRMED. BASED ON INVESTIGATION DETAILS, THE HANDPIECE PASSED ALL TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN AT THE BEGINNING OF A SURGICAL PROCEDURE. THERE HAS BEEN NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE RECIP SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |