FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 7 SAG SAW
MDR report key: 2955033
·
Received February 11, 2013
Report
- Report Number
- 0001811755-2013-00229
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 25, 2013
- Report Date
- January 25, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AND THE DEVICE IS RETURNED A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM 7 SAGITTAL SAW WAS LEAKING FROM THE TRIGGER AREA DURING SET UP FOR A PROCEDURE. THE CASE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58104 | SYSTEM 7 SAG SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | HWE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |