BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/INSERTION DHS BLADE

    MDR report key: 3160588 · Received June 10, 2013

    Report

    Report Number
    8030965-2013-02744
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    July 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED THAT THIS ARTICLE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE VISUAL INVESTIGATION HAS SHOWN THAT THE CONNECTING SCREW IS BROKEN OFF AT THE WELDING SEAM. THE INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AT THE TIME OF PRODUCTION AND THE DEVICE HISTORY RECORDS WERE RESEARCHED AS WELL. NO ABNORMAL FINDINGS WERE IDENTIFIED. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF FAILURE. IT IS POSSIBLE THAT THE BREAKAGE MIGHT HAVE BEEN CREATED DUE TO CONTINUOUS MECHANICAL LOADINGS THAT THE CONNECTING SCREW WAS SUBJECTED TO. THIS INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS, THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID.

    Description of Event or Problem · 1

    THE CONNECTING SCREW BROKE OFF THE HEXAGONAL SCREWDRIVER DURING INSERTION OF THE BLADE THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260407 CONNECSCR F/INSERTION DHS BLADE HXX SYNTHES GMBH 2260851-1

    Patients

    Seq Age Sex Outcome Treatment
    1