FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 2 HANDPIECE
MDR report key: 1813039
·
Received August 13, 2010
Report
- Report Number
- 1811755-2010-00944
- Event Type
- Malfunction
- Date Received
- August 13, 2010
- Date of Event
- June 24, 2010
- Report Date
- July 19, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVAL, BUT THE REPORTED CONDITION OF THE DEVICE OVERHEATING COULD NOT BE DUPLICATED. BASED ON THE INVESTIGATION DETAILS, WHEN THE DRILL WAS USED, IT SOUNDED LIKE DEBRIS WAS IN THE GEARTRAIN. A DEVICE CAN OVERHEAT WHEN ADDED FRICTION IS INTRODUCED DUE TO DEBRIS WITHIN THE DEVICE. THE MOTOR AND BEARINGS WERE REPLACED AND IT WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING THE SET-UP OF A SURGERY. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES WERE REPORTED. THE DRIVER WAS REPLACED WITH ANOTHER DEVICE AND THE CASE WAS COMPLETED AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 2 HANDPIECE | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENT | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |