FDA Adverse Event
Injury
Summary report: N
DUAL CUT SAGITTAL BLADE
MDR report key: 1082306
·
Received July 29, 2008
Report
- Report Number
- 9616696-2008-00029
- Event Type
- Injury
- Date Received
- July 29, 2008
- Date of Event
- June 25, 2008
- Report Date
- June 25, 2008
- Manufacturer
- STRYKER INSTRUMENTS CORK
- Product Code
- GFA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVALUATION. INVALID LOT NUMBER WAS PROVIDED BY HOSPITAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TOTAL KNEE PROCEDURE THAT THE BLADE BROKE UP BY THE BLADE MOUNT. IT WAS REPORTED THAT AN X-RAY WAS TAKEN POST OP AND THIS REVEALED METAL IN THE PATIENT. SURGICAL INTERVENTION WAS CARRIED OUT AND THE METAL WAS REMOVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL CUT SAGITTAL BLADE | SAW BLADES AND ACCESSORIES | GFA | STRYKER INSTRUMENTS CORK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |