BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø3.5 SELF-TAP L75 TAN

    MDR report key: 3161867 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03039
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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). THE INVESTIGATION OF THE COMPLAINED LOCKING SCREW SHOWS, THAT INDEED THE WRONG SCREW WAS PACKED UP. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE FOR THIS PROBLEM BUT WE SUPPOSE THAT ONE STEP DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT PROPERLY. THIS IS CLEARLY A PACKAGING FAULT. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WRONG LOCKING SCREW WAS RECEIVED IN THE PACKAGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262239 LOCKSCR Ø3.5 SELF-TAP L75 TAN KTT SYNTHES GMBH 3613060

    Patients

    Seq Age Sex Outcome Treatment
    1