FDA Adverse Event
Malfunction
Summary report: N
SAGITTAL BLADE 25.0X0.89X90MM
MDR report key: 1241907
·
Received November 19, 2008
Report
- Report Number
- 9616696-2008-00074
- Event Type
- Malfunction
- Date Received
- November 19, 2008
- Date of Event
- October 20, 2008
- Report Date
- October 20, 2008
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED BLADES WERE MEASURED AGAINST THEIR PRINTS AND ALL CRITICAL FEATURES MEASURED WERE IN SPECIFICATION. WORK ORDER DOCUMENTATION WAS REVIEWED AND ALL SPECIFICATIONS WERE MET.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT THAT THE TWO BLADES SUBJECT TO THIS MDR BROKE AT THE BLADE MOUNT. IT WAS FURTHER REPORTED THAT ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THAT THERE WAS A DELAY IN SURGERY DUE TO THE REPORTED EVENT, BUT THAT IT DID NOT AFFECT THE PATIENT'S OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGITTAL BLADE 25.0X0.89X90MM | SAW BLADES & ASSOCIATES | GFA | STRYKER IRELAND LTD. | 08196017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |