BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERONAIL SLIDING CEPHALIC SCREWS, STERILE

    MDR report key: 1891048 · Received June 29, 2010

    Report

    Report Number
    9680825-2010-00005
    Event Type
    Other
    Date Received
    June 29, 2010
    Date of Event
    January 16, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    PMA / PMN Number
    K053261
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT DOES NOT MEET THE REQUIREMENT OF MANDATORY REPORT, AS THERE ARE NO ADVERSE EFFECTS ON PT. FOLLOWING THE INDICATIONS PROVIDED IN THE "PUBLIC HEALTH NOTIFICATION: UNRETRIEVED DEVICE FRAGMENTS" ISSUED ON (B)(4) 2008, ORTHOFIX (B)(6) DECIDES TO REPORT THESE KIND OF EVENTS, ON A VOLUNTARY BASIS. THE RETURNED SCREW WAS SUBJECT TO VISUAL AND DIMENSIONAL CHECK. THE VISUAL CHECK EVIDENCED THAT THE BREAKAGE OF THE BARREL WAS A FRAGILE ONE. THE SCREW WAS HIGHLY BENT. IN SOME SITUATIONS, A HIGHLY BENT SCREW OCCURRED DUE TO EXCESSIVE LOAD APPLICATION. THE DIMENSIONAL CHECK EVIDENCED THAT THE SCREW IS CONFORMING TO ORTHOFIX DESIGN SPECIFICATIONS. THE RESULTS OF THE TECHNICAL ANALYSIS SUGGESTED THAT THE BREAKAGES OCCURRED ARE ATTRIBUTABLE TO EXCESSIVE FORCE APPLIED DURING INSERTION DUE TO A COMBINATION OF: BENDING LOAD APPLIED. INCORRECT ENGAGEMENT OF THE SCREWDRIVER INTO THE SCREWS, AS REPORTED BY THE USER. ORTHOFIX HISTORICAL RECORDS INDICATE THAT THE DEFECT RATE DURING THE PERIODS OF TIME FROM (B)(4) 2005 UP TO (B)(4) 2010 IS (B)(4). ORTHOFIX CONTINUES MONITORING THE PRODUCTS ON THE MARKET.

    Description of Event or Problem · 1

    DURING THE INSERTION, THREE VERONAIL SLIDING SCREWS BROKE. THE SMALL BROKEN PARTS WERE LEFT IN THE PT. THE DEVICES FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PT. THE USER REPORTS THAT "THE REASON IS THAT THE SCREWDRIVER HAS NOT BEEN PROPERLY TIGHTENED TO THE SCREW". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERONAIL SLIDING CEPHALIC SCREWS, STERILE VERONAIL SLIDING CEPHALIC SCREWS, STERI HSB ORTHOFIX SRL 99-T79705 20J07Z

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR