FDA Adverse Event
Malfunction
Summary report: N
REPAIR O.M.IMPACTION DRILL
MDR report key: 1661475
·
Received April 9, 2010
Report
- Report Number
- 1811755-2010-00367
- Event Type
- Malfunction
- Date Received
- April 9, 2010
- Date of Event
- December 28, 2009
- Report Date
- December 28, 2009
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZA
- PMA / PMN Number
- K961970
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE FOR THE TEMPERATURE RISE WAS PROBLEMS WITH THE CABLE/COIL ASSEMBLY ORAL MAX PART, AS WELL AS, THE DRIVESHAFT AND BEARING, WHICH WERE EACH REPLACED. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXCEEDED THE MAXIMUM TEMPERATURE RISE IN A QUALITY ASSURANCE TEST, WHICH COULD INDICATE THE DEVICE OVERHEATED OR MAY OVERHEAT. THERE WAS NO MEDICAL/SURGICAL PROCEDURE INVOLVED AT THIS TIME, SO NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR O.M.IMPACTION DRILL | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACH | DZA | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |