FDA Adverse Event
Malfunction
Summary report: N
REPAIR U2 DRILL
MDR report key: 1902888
·
Received November 12, 2010
Report
- Report Number
- 1811755-2010-01671
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 21, 2010
- Report Date
- October 21, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DRILL ATTACHMENT WAS RECEIVED BY THE MFR AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED, AND EXTENSIVE CORROSION WAS DISCOVERED WITHIN THE MOTOR ASSEMBLY, ROTOR ASSEMBLY, AND BEARINGS. THE PRESENCE OF CORROSION CAN LEAD TO INCREASED FRICTION BETWEEN ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED. THE MOTOR ASSEMBLY, ROTOR ASSEMBLY, AND BEARINGS WERE REPLACED AND THE DEVICE WAS RETURNED TO THE USER FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR U2 DRILL | DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |