FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1873419
·
Received September 17, 2010
Report
- Report Number
- 1811755-2010-01188
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- August 13, 2010
- Report Date
- August 23, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 OVERHEATING WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH A DAMAGED NOSE CONE, SPINDLE HOUSING, DRIVESHAFT ASSEMBLY AND BEARINGS, WHICH WERE EACH REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THERE WAS NO REPORTED PT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE IMPACTION DRILL | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |