FDA Adverse Event
Malfunction
Summary report: N
SD/PD LONG CURVED
MDR report key: 1942242
·
Received December 22, 2010
Report
- Report Number
- 1811755-2010-02092
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- November 29, 2010
- Report Date
- December 8, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION RESULTS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A MFR FIELD SERVICE TECHNICIAN, THE DRILL ATTACHMENT 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 | SD/PD LONG CURVED | DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC | ERL | STRYKER INSTRUMENTS KALAMAZOO | 09063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |