FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 2 HANDPIECE
MDR report key: 1853858
·
Received September 7, 2010
Report
- Report Number
- 1811755-2010-01065
- Event Type
- Malfunction
- Date Received
- September 7, 2010
- Date of Event
- August 6, 2010
- Report Date
- August 6, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MFR FOR INVESTIGATION. AN EVAL WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE DRIVETRAIN CONNECTION WAS WORN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING AFTER THE COMPLETION OF AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 2 HANDPIECE | SURGICAL INSTRUMENTS AND ACCESSORIES/ATTACHM | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |