BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VILEX 3.0MM CANNULATED LAG SCREW

    MDR report key: 2271801 · Received September 19, 2011

    Report

    Report Number
    1051526-2011-00003
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 19, 2011
    Manufacturer
    VILEX IN TENNESSEE, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VILEX WAS CONTACTED BY OUR LOCAL SALES REP AND WAS NOTIFIED THAT A 3.0MM SCREW BROKE DURING SURGERY. REP SENT COPY OF X-RAY SHOWING SCREW RIGHT BEFORE BREAKING POINT. DOCTOR PLACED THE GUIDE WIRE TOO CLOSE TO THE POSTERIOR CORTEX AND NOT IN THE CANCELLOUS BONE. DOCTOR DID NOT PRE-DRILL. NO SCREW WILL GO THROUGH CORTICAL BONE IN THE MID-FOOT WITHOUT PRE-DRILLING. DOCTOR REMOVED PORTION OF THE SCREW AND REMAINING PORTION IS IMPLANTED IN PT. DOCTOR DID NOT KEEP THE PORTION OF THE SCREW HE REMOVED. DOCTOR PRE-DRILLED AND IMPLANTED A SECOND SCREW WITH NO PROBLEMS. A 3.0MM SCREW IS TYPICALLY NOT USED IN THE MID-FOOT. NO OTHER REPORTS OF BREAKAGE HAVE BEEN RECEIVED INVOLVING THIS PRODUCT. LOT NUMBER WAS NOT RECORDED BY THE DOCTOR. WITHOUT THE PORTION OF THE SCREW THAT WAS REMOVED, NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT A 3.0MM SCREW BROKE DURING SURGERY. DOCTOR PLACED THE GUIDE WIRE ALONG THE EDGE OF THE POSTERIOR CORTEX (CLOSE TO THE JOINT) NOT IN THE CANCELLOUS BONE. DOCTOR DID NOT PREDRILL. SCREW BROKEN IN HALF. DOCTOR REMOVED THE SCREW EXCEPT FOR THE BROKEN PORTION WHICH REMAINED IN THE PT. DOCTOR DID NOT KEEP THE PORTION OF THE SCREW HE WAS ABLE TO RETRIEVE, THEREFORE NO PRODUCT WAS RETURNED TO VILEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VILEX 3.0MM CANNULATED LAG SCREW 3.0MM TITANIUM LAG SCREW HWC VILEX IN TENNESSEE, INC. S30-28T-11 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK