FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 3
MDR report key: 3043496
·
Received April 9, 2013
Report
- Report Number
- 0001811755-2013-00729
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 20, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED FOR EVALUATION FOR THE REPORTED OVERHEATING. UPON DISASSEMBLY FOR VISUAL EXAMINATION, THE ALLEGED FAILURE COULD NOT BE DUPLICATED AND NO COMPONENTS WERE IDENTIFIED WHICH WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE, AND RETURNED TO THE USER FACILITY.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORDLESS DRIVER WAS OVERHEATING DURING A PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORDLESS DRIVER WAS OVERHEATING DURING A PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145758 | CORDLESS DRIVER 3 | ARTHROSCOPE | HRX | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |