FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 2964585
·
Received February 15, 2013
Report
- Report Number
- 0001811755-2013-00301
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 31, 2013
- Report Date
- January 31, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING THE DEVICE EVALUATION, THE REPORTED OVERHEATING COULD NOT BE CONFIRMED. HOWEVER, A WORN COUPLER WAS FOUND, WHICH MAY LEAD TO INTERMITTENT FRICTION AND MAY CAUSE OVERHEATING.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY, THE DRILL WAS OVERHEATING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY, THE DRILL WAS OVERHEATING. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67061 | CORE IMPACTION DRILL | DRIVER, WIRE, AND BONE DRILL, MANUAL | DZJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |