FDA Adverse Event
Malfunction
Summary report: N
LOANER SYSTEM 6 SAG SAW
MDR report key: 2050026
·
Received March 14, 2011
Report
- Report Number
- 1811755-2011-00788
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 15, 2011
- Report Date
- February 15, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND A SAMPLE WAS TAKEN OF THE SUBSTANCE OF FURTHER ANALYSIS. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A SUBSTANCE INSIDE OF THE HANDPIECE. THIS WAS FOUND WHILE DEVICE WAS BEING REPAIRED AT THE MANUFACTURER. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOANER SYSTEM 6 SAG SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |