FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1970370
·
Received January 18, 2011
Report
- Report Number
- 1811755-2011-00149
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- August 11, 2010
- Report Date
- August 11, 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 DEVICE WAS RECEIVED FOR REPAIRS AND DURING QUALITY TESTING IT FAILED THE MAXIMUM ALLOWABLE TEMPERATURE RISE. FURTHER INVESTIGATION REVEALED THE MOTOR PINS AND BALL BEARINGS WERE WORN. THE MOTOR AND BEARING WERE REPLACED ALONG WITH OTHER COMPONENT PARTS THAT WERE WORN. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
A STRYKER CORE IMPACTION DRILL THAT WAS SENT IN FOR REPAIRS OVERHEATED DURING THE QUALITY INVESTIGATION TESTING. THERE WAS NO PT INVOLVEMENT AND THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE IMPACTION DRILL | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |