BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    135 DEG LCP DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES

    MDR report key: 2900129 · Received January 7, 2013

    Report

    Report Number
    3003506883-2013-00019
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 9, 2012
    Report Date
    December 10, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K033556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING ENGINEER EVALUATED THE DEVICE AND INDICATED PART NUMBER 282.612 IS AN ASSEMBLY COMPOSED OF TWO SUBCOMPONENTS 282.610.2 AND 282.610.1. THE AS RECEIVED CONDITION OF THE PLATE SUBCOMPONENT- PART NUMBER 282.610.1-- WAS INTACT WITH SOME MINOR MARKING/SCRATCHING CONSISTENT WILL NORMAL FIELD USAGE. ALL RELATED PERTINENT DIMENSIONAL FEATURES WERE OBTAINABLE, MEASURED AND PASSED PER INSPECTION SHEET. THE AS RECEIVED CONDITION OF THE INSERT SUBCOMPONENT- PART NUMBER 282.610.2- WAS INTACT WITH SOME MINOR DEFORMATION CONSISTENT WILL THE ASSEMBLY PROCESS. RELATED PERTINENT DIMENSIONAL FEATURES THAT WERE OBTAINABLE, MEASURED AND PASSED PER INSPECTION SHEET. ONE FEATURE WAS DAMAGED DUE TO ASSEMBLY. THE DAMAGE DOES NOT CONTRIBUTE TO THE FAILURE CONDITION AND IS STANDARD PER THE ASSEMBLY PROCESS. INSPECTION / MEASUREMENT OF THE RETURNED PART SHOWED ALL UNDAMAGED FEATURES MEET DIMENSIONAL AND VISUAL REQUIREMENTS FOR PERTINENT FEATURES THAT COULD BE RELATED TO THE CUSTOMER COMPLAINT. ONE FEATURE WAS DAMAGED WAS UNABLE TO ACCURATELY EVALUATED. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THE LOCKING MECHANISM INSIDE THE BARREL OF THE LCP DHHS SIDEPLATE SEEMED BROKEN AND WOULD NOT WORK. THE SURGEON HAD TO USE A DIFFERENT PLATE. THE SURGEON REPORTED THE PATIENT WAS COMPLETELY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8057 135 DEG LCP DHHS(TM) SIDEPLATE-STD BARREL 4 HOLES LCP DHHS SIDEPLATE KTT SYNTHES ELMIRA 6616844

    Patients

    Seq Age Sex Outcome Treatment
    1