FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1902881
·
Received November 12, 2010
Report
- Report Number
- 1811755-2010-01665
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 22, 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
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS REC'D AT THE MFR FOR SERVICE AND EVAL. A CONDITION OF THE DEVICE OVERHEATING WAS FOUND WHEN THE DRILL EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE MOTOR CARTRIDGE, ROTOR ASSEMBLY, AND BEARINGS. THOSE PARTS WERE REPLACED ALONG WITH THE DRIVESHAFT AND OTHER COMPONENTS. SERVICE WILL REPAIR AND RETURN THE DEVICE TO THE CUSTOMER.
Description of Event or Problem · 1
THE HANDPIECE WAS RETURNED TO THE MFR FOR SERVICE, AND DURING THE INVESTIGATION, THE DEVICE EXCEEDED THE MAXIMUM ALLOWED TEMPERATURE RISE ON THE SPINDLE HOUSING. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES WHEN THIS EVENT OCCURRED.
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 |