FDA Adverse Event
Malfunction
Summary report: N
CORE SUMEX DRILL
MDR report key: 2941940
·
Received December 21, 2012
Report
- Report Number
- 1811755-2012-04295
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 19, 2012
- Report Date
- November 19, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
UPON VISUAL INSPECTION, WORN PARTS WERE DISCOVERED INCLUDING THE ROTOR AND MOTOR. THE CABLE ASSEMBLY WA ALSO FOUND TO BE DAMAGED.
Description of Event or Problem · 1
THE CORE SUMEX DRILL WAS RETURNED FOR SVC. UPON EVALUATION AT THE MFR, IT DISPLAYED A BIAS CURRENT ERROR SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE SUMEX DRILL | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |