FDA Adverse Event
Malfunction
Summary report: N
OSCILLATING AND SAGITTAL BLADE
MDR report key: 2093554
·
Received April 5, 2011
Report
- Report Number
- 9616696-2011-00049
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 10, 2011
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE BLADE SUBJECT TO THIS MDR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT THE BLADE WAS BROKEN AT THE MOUNT. 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 UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT RESULT IN ANY DELAY AND THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSCILLATING AND SAGITTAL BLADE | GFA | STRYKER IRELAND LTD. | 09107017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |