FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE IMPACTION DRILL
MDR report key: 1860226
·
Received September 21, 2010
Report
- Report Number
- 1811755-2010-01218
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- August 25, 2010
- Report Date
- August 25, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A F/U REPORT WILL BE SUBMITTED AFTER QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE WAS SMOKING. AT THIS TIME, IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. MULTIPLE ATTEMPTS TO GATHER ADD'L INFO FROM THE ACCOUNT WERE UNSUCCESSFUL.
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 |