FDA Adverse Event
Malfunction
Summary report: N
QUICK-COUPLING GAUTHIER 103800
MDR report key: 1479918
·
Received July 10, 2009
Report
- Report Number
- 9615741-2009-00020
- Event Type
- Malfunction
- Date Received
- July 10, 2009
- Date of Event
- June 16, 2009
- Report Date
- July 10, 2009
- Manufacturer
- NEWDEAL S.A.S.
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIALED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE DEVICE HANDLE BROKE DURING A PROCEDURE WHEN THE SURGEON WAS ADVANCING A LARGE QWIX SCREW. THE PROCEDURE WAS COMPLETED USING A POWER SCREWDRIVER. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICK-COUPLING GAUTHIER 103800 | NA | LXH | NEWDEAL S.A.S. | EAFF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |