BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIX BLADE 105MM

    MDR report key: 2955529 · Received February 11, 2013

    Report

    Report Number
    3003506883-2013-10018
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 29, 2011
    Report Date
    December 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDO
    PMA / PMN Number
    K981757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE PRODUCT EVALUATION REVEALED THAT THE HELIX BLADE WAS RECEIVED WITH THE BROKEN THREADED PORTION OF THE LCP-DHHS COUPLING SCREW STUCK IN THE THREADED CANNULATION OF THE HELIX BLADE. THE HELIX BLADE DID NOT SEEM TO BE USED. THE BROKEN THREADED PORTION OF THE LCP-DHHS COUPLING SCREW WAS TAKEN OUT OF THE THREADED CANNULATION OF THE HELIX BLADE. THE RAW MATERIAL OF THE HELIX BLADE WAS VERIFIED TO BE 316L. THE THREAD DIAMETER AND DEPTH WERE VERIFIED USING A THREAD DEPTH GAGE. THE CANNULATION HOLE SIZE WAS ALSO VERIFIED. BASED ON THE EVALUATION OF THE HELIX BLADE, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STAND POINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    DURING A DYNAMIC HELICAL HIP SYSTEM PROCEDURE, TECHNICIAN WAS TIGHTENING SCREW FOR INSERTION AND THE SCREW BROKE INTO THE HELICAL BLADE. A BACK UP HELICAL BLADE WAS USED AND THE SURGEON PROCEEDED WITHOUT USING A CONNECTING SCREW. PROCEDURE WAS SUCCESSFUL AND PATIENT WAS NOT HARMED. THE SCREW AND THE BLADE ARE AVAILABLE FOR RETURN. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57955 HELIX BLADE 105MM JDO SYNTHES MONUMENT 4176623

    Patients

    Seq Age Sex Outcome Treatment
    1