FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL HIGH TORQUE DRILL
MDR report key: 1873504
·
Received October 14, 2010
Report
- Report Number
- 1811755-2010-01402
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- September 22, 2010
- Report Date
- September 27, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE MANUFACTURER'S FIELD SERVICE TECHNICIAN, THAT THE DEVICE 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 | DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |