FDA Adverse Event
Malfunction
Summary report: N
INTRA ORAL BLADE
MDR report key: 1854061
·
Received September 2, 2010
Report
- Report Number
- 9616696-2010-00278
- Event Type
- Malfunction
- Date Received
- September 2, 2010
- Date of Event
- August 4, 2010
- Report Date
- August 5, 2010
- Manufacturer
- STRYKER IRELAND LTD.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 THAT THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE SURGEON REMOVED ALL BROKEN PIECES FROM 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 | INTRA ORAL BLADE | SAW BLADES & ACCESSORIES | GFA | STRYKER IRELAND LTD. | 09097027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |