FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 3
MDR report key: 2990202
·
Received March 5, 2013
Report
- Report Number
- 0001811755-2013-00440
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 20, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING THE DEVICE EVALUATION, A SHORT CIRCUIT WAS FOUND IN THE MOTOR WINDING, WHICH IS A PROBABLE CAUSE OF THE REPORTED OVERHEATING. THE DEVICE HAS BEEN REPAIRED, BUT IT HAS NOT BEEN RETURNED TO THE USER FACILITY AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS OVERHEATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93481 | CORDLESS DRIVER 3 | ARTHROSCOPE | HRX | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |