FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 3013229
·
Received March 20, 2013
Report
- Report Number
- 0001811755-2013-00561
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND THROUGHOUT THE INSIDE OF THE HAND PIECE AND EVIDENCE OF A THERMAL EVENT WAS FOUND ON THE CONTACT PINS. ADDITIONALLY, THERE WAS EVIDENCE OF THE THIRD PARTY SERVICE BEING PERFORMED ON THE UNIT.
Description of Event or Problem · 1
THE DRILL WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND UPON EVALUATION IT WAS DISCOVERED THAT THE DEVICE OPERATED WITHOUT THE TRIGGER BEING ACTIVATED AND A BIAS CURRENT ERROR WAS DISPLAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115604 | CORE MICRO DRILL | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |