FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE
MDR report key: 2000587
·
Received February 1, 2011
Report
- Report Number
- 1811755-2011-00281
- 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
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE EVENT WAS DUPLICATED. THE ANTI ROTATION PIN WAS STUCK UNDER THE CARRIAGE ASSEMBLY. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ROTARY DRILL WOULD NOT STOP RUNNING. THIS WAS FOUND PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |