FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 SAGITTAL SAW
MDR report key: 2961375
·
Received February 14, 2013
Report
- Report Number
- 0001811755-2013-00279
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 28, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR EVALUATION AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED AND THE DEVICE IS RETURNED A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4): THE DEVICE IS NOT BEING RETURNED TO THE MANUFACTURER FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TRIGGER OF THE SYSTEM 5 SAGITTAL SAW IS STUCK. THIS WAS NOTICED DURING INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65503 | SYSTEM 5 SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | KIJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |