FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL HIGH TORQUE DRILL
MDR report key: 2201023
·
Received July 1, 2011
Report
- Report Number
- 1811755-2011-02365
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 9, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPLACED WORN BEARINGS AND ROTOR ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED BY THE MANUFACTURER SALES REPRESENTATIVE, THE DRILL HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL HIGH TORQUE DRILL | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |