FDA Adverse Event
Malfunction
Summary report: N
SCREW FOR COMPRESSION FORECEPS DIA. 4XL55
MDR report key: 2487867
·
Received March 6, 2012
Report
- Report Number
- 9615741-2012-00015
- Event Type
- Malfunction
- Date Received
- March 6, 2012
- Date of Event
- February 29, 2012
- Report Date
- March 6, 2012
- Manufacturer
- NEW DEAL SAS
- Product Code
- HRS
- PMA / PMN Number
- K073375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE REPORTER STATED THAT DURING A LEFT ANKLE ARTHRODESIS SURGICAL PROCEDURE USING THE TIBIAXYX SYSTEM, THE SURGEON INSERTED THE COMPRESSION SCREW INTO THE TIBIA AND COMPRESSED THE JOINT USING THE COMPRESSION FORCEPS (PRODUCT CATALOGUE NUMBER 219960). WHEN HE TRIED TO REMOVE THE COMPRESSION SCREW USING A SCREWDRIVER, THE HEAD OF THE SCREW BROKE OFF. AFTER SEVERAL ATTEMPTS USING DIFFERENT INSTRUMENTS, THE SURGEON REMOVED THE SCREW USING A PAIR OF PLIERS. THE SURGERY WAS PROLONGED BY ABOUT THIRTY MINUTES. THERE WAS NO REPORTED ADVERSE OUTCOME FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREW FOR COMPRESSION FORECEPS DIA. 4XL55 | NA | HRS | NEW DEAL SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |