FDA Adverse Event
Malfunction
Summary report: N
LOANER SYSTEM 5 SAGITTAL SAW
MDR report key: 1970376
·
Received January 18, 2011
Report
- Report Number
- 1811755-2011-00154
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 21, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE EVAL IS ANTICIPATED, BUT HAS NOT YET BEGUN. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE DEVICE WAS AT THE MFR A REPAIR TECH FOUND GREASE COMING OUT OF THE BLADE MOUNT AREA. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOANER SYSTEM 5 SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |