BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG LCP DHHS SIDEPLATE-STD BARREL 4 H

    MDR report key: 2945293 · Received February 1, 2013

    Report

    Report Number
    3003506883-2013-10007
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SYNTHES (USA) ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K033556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE VISUAL EVALUATION REVEALED THE DEVICE WAS RECEIVED WITH NO APPARENT PHYSICAL DAMAGE TO ANY OF PART FEATURES. THE SLOTTED KEY HAD BEEN PUSHED IN PAST THE RETAINING GROOVE POST PRODUCTION. THE PART MET ALL COSMETIC AND DIMENSIONAL CRITERIA AT THE TIME OF ITS MANUFACTURE AND RELEASE. ALL DIMENSIONAL FEATURES VERIFIED WERE ASSOCIATED WITH THE BARREL PORTION OF THE PART DUE TO DIRECTION OF THE COMPLAINT. BASED ON THE RETURNED DEVICE EVALUATION AND THE REPORTED EVENT, THE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DYNAMICAL HELICAL HIP SCREW (DHHS) NON-DISPLACED FRACTURE PROCEDURE, THE SURGEON INSERTED THE HELIX BLADE AND FOUND IT TIGHT TO INSERT. THE SURGEON REMOVED THE OUTER PART OF THE AIMING ARM OFF AND TAPPED THE BLADE LIGHTLY IN 2 MM. THE SURGEON THEN WENT TO INSERT THE 130 DEGREES LOCKING COMPRESSION PLATE (LCP) SIDEPLATE AND IT WOULD NOT ADVANCE. THE SURGEON TRIED TO REMOVE THE PLATE AND THE BLADE CAME OUT WITH THE PLATE AS THEY WERE STUCK TOGETHER. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S HARDWARE. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44587 130 DEG LCP DHHS SIDEPLATE-STD BARREL 4 H KTT SYNTHES (USA) ELMIRA 6525202

    Patients

    Seq Age Sex Outcome Treatment
    1 HELIX BLADE 80MM