FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 2 HANDPIECE
MDR report key: 3093537
·
Received May 6, 2013
Report
- Report Number
- 0001811755-2013-01025
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION NON-STRYKER COMPONENTS WERE FOUND.
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
WHILE TESTING THE CORDLESS DRIVER 2 HANDPIECE IT RAN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Description of Event or Problem · 1
WHILE TESTING THE CORDLESS DRIVER 2 HANDPIECE IT RAN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196834 | CORDLESS DRIVER 2 HANDPIECE | ARTHROSCOPE | HRX | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |