FDA Adverse Event
Malfunction
Summary report: N
SAGITTAL BLADE
MDR report key: 2101866
·
Received April 29, 2011
Report
- Report Number
- 9616696-2011-00064
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 17, 2011
- Report Date
- April 4, 2011
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BLADE AND BROKEN PIECES SUBJECT TO THIS INVESTIGATION WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT BOTH TABS WERE BROKEN FROM THE MOUNT OF THE BLADE. THE RETURNED PART WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS MULTI-FACTORIAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE BLADE BROKE AT THE MOUNT. IT WAS FURTHER REPORTED ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGITTAL BLADE | GFA | STRYKER IRELAND LTD. | 10281017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |