FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE
MDR report key: 2213803
·
Received August 4, 2011
Report
- Report Number
- 1811755-2011-02792
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 15, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE BACK NUT MAY UNTHREAD DUE TO AUTOCLAVING CYCLES AND THE VIBRATION ON THE HANDPIECE DURING USE. THE BACK NUT AND HOUSING WERE EACH REPLACED ALONG WITH OTHER COMPONENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BACK SCREW CAME OUT AND THE DEVICE FELL APART. THE DEVICE WAS LEFT IN A REPAIR BIN. PT INVOLVEMENT IS UNK. ADVERSE CONSEQUENCES ARE UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |