FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 1841991
·
Received August 24, 2010
Report
- Report Number
- 1811755-2010-01006
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- July 27, 2010
- Report Date
- July 28, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE RUNNING ON ITS OWN WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE UPPER ROTOR BEARING, WHICH WAS REPLACED ALONG WITH THE MOTOR ASSEMBLY AND PRESS PLUGS. THE ITEM WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN ON ITS OWN DURING A SURGICAL PROCEDURE. THERE HAS BEEN NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS SUCCESSFULLY COMPLETED AS PLANNED WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |