FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 SAGITTAL SAW
MDR report key: 2942606
·
Received February 4, 2013
Report
- Report Number
- 0001811755-2013-00174
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 23, 2013
- Report Date
- January 23, 2013
- 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
IT WAS NOTED DURING FAILURE ANALYSIS THAT BASED ON A REVIEW OF COMPLAINT TRENDING, POSSIBLE CAUSES INCLUDE STRESS FROM VIBRATIONS OR THERMAL CYCLES DUE TO NORMAL USE OF THE HANDPIECE.
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE SYSTEM 5 SAGITTAL SAW WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THE BLADE MOUNT IS CHIPPING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Description of Event or Problem · 1
THE SYSTEM 5 SAGITTAL SAW WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THE BLADE MOUNT IS CHIPPING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47054 | SYSTEM 5 SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | KIJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |