FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 SAGITTAL SAW
MDR report key: 2042797
·
Received March 30, 2011
Report
- Report Number
- 1811755-2011-01014
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 3, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN EVALUATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLADE WAS BREAKING AT THE CONNECTIONS WHERE THE BLADES ARE INSERTED INTO THE HANDPIECE. THIS OCCURRED DURING A TOTAL KNEE PROCEDURE. THEY OPENED ANOTHER SET AND COMPLETED THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 6 SAGITTAL SAW | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |