FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1882961
·
Received October 22, 2010
Report
- Report Number
- 1811755-2010-01465
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 24, 2010
- Report Date
- September 30, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE ROTOR, MOTOR, AND BEARINGS, WHICH WERE EACH REPLACED. SVC WILL REPAIR AND RETURN THE DEVICE TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING PRIOR TO THE START OF AN ORAL SURGERY. THERE WAS NO PT INVOLVEMENT. 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 ACCESORIES/ATTAC | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |