BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL-INSERTER

    MDR report key: 3192554 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04144
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    August 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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. (B)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE PROSTHESIS DID NOT REMAIN ON THE INSERTING DEVICE. THE ITEM WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. DURING THE PERFORMANCE TEST ON THE IMPLANT INSERTER, NO FAULTY FUNCTIONS WERE DETECTED AND THE IMPLANT WAS PICKED UP PROPERLY AND HELD. EVEN DURING THE VISUAL INSPECTION, NO VISIBLE DAMAGES WERE DETECTED. HOWEVER, IT WAS FOUND THAT THE WELD SEAM ON THE IMPLANT INSERTER SHAFT WAS BROKEN. THIS COULD ALSO BE CAUSED BY HAMMER BLOWS TO THE REAR PART OF THE IMPLANT INSERTER. THE EXACT CAUSE OF THIS PROBLEM CANNOT BE DETERMINED BUT WE CAN STATE THAT THE ITEM FULLY COMPLIES WITH OUR REQUIREMENTS. NO PRODUCT DEFECTS WERE DETECTED.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROSTHESIS DID NOT REMAIN ON INSERTING DEVICE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293784 IMPL-INSERTER LXH SYNTHES GMBH 3527169

    Patients

    Seq Age Sex Outcome Treatment
    1