FDA Adverse Event
Malfunction
Summary report: N
CORDLESS DRIVER 2 HANDPIECE
MDR report key: 2000555
·
Received February 1, 2011
Report
- Report Number
- 1811755-2011-00293
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 5, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVALUATION. A CONDITION OF STICKY TRIGGER WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE TRIGGER ASSEMBLY IN ADDITION TO OTHER COMPONENTS WHICH WERE REPLACED. SERVICE REPAIRED AND RETURNED THE DEVICE 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 PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORDLESS DRIVER 2 HANDPIECE | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |