FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
MDR report key: 4172398
·
Received October 15, 2014
Report
- Report Number
- 0001811755-2014-03612
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 17, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED RUN-ON WAS CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. UPON DISASSEMBLY, A BROKEN PIN WAS FOUND, WHICH CAN LEAD TO THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE USER FACILITY THE TRIGGER OF THE DEVICE WAS GETTING STUCK IN THE ON POSITION, A CONDITION WHICH CAUSED THE DEVICE TO RUN WITHOUT USER ACTIVATION. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654706 | SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | KIJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |