FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1902876
·
Received November 12, 2010
Report
- Report Number
- 1811755-2010-01663
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 25, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR SERVICE AND EVAL, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED WHEN THE DRILL EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE ON THE SPINDLE HOUSING. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE MOTOR CARTRIDGE AND CORROSION ON COMPONENTS. SERVICE WILL REPLACE ALL NECESSARY PARTS AND REPAIR AND REBUILD THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING AN ORAL SURGERY. THE PROCEDURE WAS CONTINUED 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 ACCESSORIES/ATTAC | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |