FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 5 SAGITTAL SAW
MDR report key: 2050018
·
Received March 14, 2011
Report
- Report Number
- 1811755-2011-00795
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 17, 2011
- Report Date
- February 17, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS RETURNED AND AN EVALUATION IS COMPETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT OIL WAS COMING OUT OF THE RELEASE BUTTON OF THE SAW. THIS WAS DISCOVERED DURING TESTING. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 5 SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |