FDA Adverse Event
Malfunction
Summary report: N
SAGITTAL SAW
MDR report key: 2003892
·
Received February 7, 2011
Report
- Report Number
- 1811755-2011-00358
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 10, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. THE DEVICE WAS REPAIRED AND RETURNED TO THE ACCOUNT. THIS REPORT WILL BE UPDATED WHEN THE EVALUATION OF THE EVENT IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CASE THE HANDPIECE FELL APART OVER THE STERILE FIELD AND PATIENT. THERE WAS A 1/2 HOUR DELAY TO CLEAN UP AND RESTART THE PROCEDURE. ATTEMPTS HAVE BEEN MADE TO COLLECT ADDITIONAL INFORMATION FROM THE ACCOUNT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGITTAL SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |