BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC

    MDR report key: 3190940 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-02703
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    February 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    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 DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION SHOWED THAT AT FIRST THE TIP WAS TWISTED AND THEN BROKE OFF. UNFORTUNATELY, WE CAN NO LONGER DETERMINE WHAT THE EXACT REASON WAS THAT LEAD TO THIS DAMAGE. BASED ON THE FINDING, WE ARE ASSUMING THAT AN EXCESSIVE MECHANICAL LOAD LEAD TO THE DAMAGING OF THE TIP. THE FRACTURE SURFACE IS HOMOGENEOUS, WHICH REFERS TO FLAWLESS MATERIAL QUALITY. FURTHER INVESTIGATIONS OF THE MANUFACTURE AND MATERIAL DOCUMENTS SHOWED CONFORMITY WITH THE SPECIFICATIONS. NO PRODUCT DEFECTS WERE FOUND.

    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.

    Description of Event or Problem · 1

    THE TIP OF THE INSTRUMENT IS BROKEN. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290015 3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC HXX SYNTHES GMBH 5333971

    Patients

    Seq Age Sex Outcome Treatment
    1