FDA Adverse Event
Malfunction
Summary report: N
SAGITTAL SAW ATTACHMENT
MDR report key: 1924686
·
Received December 9, 2010
Report
- Report Number
- 1811755-2010-01992
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 17, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATTACHMENT BROKE DURING USE. A PIECE EJECTED FROM THE INSTRUMENT AND WAS RECOVERED. IT IS UNCERTAIN IF ANY SMALL FRAGMENTS WERE NON-RECOVERED. NO FURTHER INFO HAS BEEN RECEIVED DESPITE NUMEROUS ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGITTAL SAW ATTACHMENT | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |