SYSTEM 5 SAGITTAL SAW
Report
- Report Number
- 0001811755-2013-00359
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THE COMPLAINT WAS CONFIRMED. THE HANDPIECE WAS FOUND TO HAVE POWER LOSS DUE TO A FAULTY CONTROLLER. BASED ON A REVIEW OF COMPLAINT TRENDING, A FAULTY CONTROLLER CAN CAUSE INTERMITTENT OR COMPLETE LOSS OF POWER.
THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.
IT WAS REPORTED THAT THE SYSTEM 5 SAGITTAL SAW HAD NO POWER DURING A PROCEDURE, WHICH RESULTED IN A 30 MINUTE DELAY IN THE CASE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE SYSTEM 5 SAGITTAL SAW HAD NO POWER DURING A PROCEDURE, WHICH RESULTED IN A 30 MINUTE DELAY IN THE CASE. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78536 | SYSTEM 5 SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | KIJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |