FDA Adverse Event
Malfunction
Summary report: N
QWIX CANNULATED DRILL FOR 7.5MM SCREWS
MDR report key: 1303818
·
Received January 6, 2009
Report
- Report Number
- 9615741-2008-00047
- Event Type
- Malfunction
- Date Received
- January 6, 2009
- Date of Event
- December 15, 2008
- Report Date
- January 5, 2009
- Manufacturer
- NEWDEAL S.A.
- Product Code
- HTW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE CANNULATED SCREW DRIVER BIT BROKE OFF IN THE PATIENT DURING A SUBTALAR FUSION PROCEDURE WHILE IMPLANTING A SCREW OVER THE 2.5MM K WIRE. THE FRAGMENT WAS LOCATED AND REMOVED AT THE TIME OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QWIX CANNULATED DRILL FOR 7.5MM SCREWS | CANNULATED DRILL FOR 7.5MM SCREWS | HTW | NEWDEAL S.A. | EBJ1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |