FDA Adverse Event
Malfunction
Summary report: N
OSCILLATING AND SAGITTAL BLADE
MDR report key: 1922482
·
Received November 16, 2010
Report
- Report Number
- 9616696-2010-00336
- Event Type
- Malfunction
- Date Received
- November 16, 2010
- Date of Event
- October 19, 2010
- Report Date
- October 21, 2010
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE BLADE AND THE BROKEN PIECE OF THE BLADE SUBJECT TO THIS MDR WERE RETURNED FOR EVAL. IT WAS VISUALLY CONFIRMED THAT ONE SECTION OF THE MOUNT OF THE BLADE WAS BROKEN. THE RETURNED BLADE WAS MEASURED WHERE POSSIBLE AND ALL CRITICAL SPECIFICATIONS WERE MET. LOT NUMBER INFO WAS NOT PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THE BROKEN PIECE DID NOT FALL INTO THE SURGICAL SITE. IT WAS FURTHER REPORTED THAT ANOTHER BLADE WAS READILY AVAILABLE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSCILLATING AND SAGITTAL BLADE | SAW BLADES & ACCESSORIES | GFA | STRYKER IRELAND LTD. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |