FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL HIGH TORQUE DRILL
MDR report key: 1942302
·
Received December 22, 2010
Report
- Report Number
- 1811755-2010-02111
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 13, 2010
- Report Date
- December 13, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RECEIVED, AND IF THE INVESTIGATION RESULTS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE USER FACILITY THAT THE DRILL HEATED UP. PATIENT INVOLVEMENT AND ADVERSE CONSEQUENCES ARE UNKNOWN. THE CUSTOMER INDICATED THAT NO ELSE COULD PROVIDE FURTHER EVENT DETAILS, SO ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL.
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 |