FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 3
MDR report key: 2004017
·
Received February 7, 2011
Report
- Report Number
- 1811755-2011-00367
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- December 29, 2010
- Report Date
- January 11, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE FORWARD TRIGGER HAD SOME DAMAGE DUE TO BEING IMPACTED INTO THE SAFETY BAR. THE HANDSWITCH NEEDED TO BE REPAIRED AND THERE WAS A BAD WELD. THE TRIGGER SHAFT AND SAFETY BAR WERE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE HANDPIECE HAD A STICKY TRIGGER. THERE WAS NO PATIENT INVOLVEMENT AND THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 3 | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |