FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1813034
·
Received August 12, 2010
Report
- Report Number
- 1811755-2010-00941
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Date of Event
- July 20, 2010
- Report Date
- July 20, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS A CORRODED DRIVESHAFT AND WORN ROTOR, WHICH WERE EACH REPLACED ALONG WITH THE NOSE CONE, BEARING STOP, AND OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING AN ORAL SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE IMPACTION DRILL | SURGICAL INSTRUMENT MOTORS AND ACCESSORIS/ATTAC | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |