BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT HOLDER FOR

    MDR report key: 3001827 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-10096
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 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. SUBJECT DEVICE HAS BEEN RECEIVED AND EVALUATED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. A MICROSCOPIC VIEW OF THE FRACTURED SURFACE DID NOT SHOW ANY ANOMALIES. THE REMAINING THREADED PORTION MET OUR SPECIFICATIONS. THE TIP BROKE OFF DUE TO MECHANICAL OVERLOADING. NO MANUFACTURING RELATED FAULT WAS FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE IMPLANT HOLDERS TIP BROKE OFF. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59247 IMPLANT HOLDER FOR LXH SYNTHES GMBH 2468931

    Patients

    Seq Age Sex Outcome Treatment
    1