FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1853732
·
Received August 30, 2010
Report
- Report Number
- 1811755-2010-01052
- Event Type
- Malfunction
- Date Received
- August 30, 2010
- Date of Event
- February 12, 2010
- Report Date
- February 12, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. A CONDITION OF THE DEVICE OVERHEATING WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THERE WAS EXCESSIVE NOISE AND VIBRATION COMING FROM THE MOTOR ASSEMBLY. SERVICE REPLACED THE DRIVE SHAFT AND SPINDLE HOUSING AND RETURNED THE DEVICE TO THE CUSTOMER.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE DRILL EXCEEDED MAXIMUM TEMPERATURE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATIONS OF ADVERSE CONSEQUENCES FROM THE ACCOUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE IMPACTION DRILL | BONE CUTTING INSTRUMENTS AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |