BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT-3.5-HEX SELF-HOLD

    MDR report key: 3191541 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-03287
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 21, 2011
    Report Date
    October 12, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE WAS EVIDENCE THAT THE TIP OF THE INSTRUMENT HAD FORCES PLACED UPON IT THAT WERE IN EXCESS OF THOSE EXPECTED. THE INVESTIGATION OF THE COMPLAINED SCREWDRIVER SHOWS THAT TIP IS INDEED BROKEN OFF-REMAINING TIP BADLY TWISTED. THERE MUST HAVE BEEN CONSIDERABLE FORCE, AS THE SHAFT IS JAMMED INTO THE HANDLE AND CANNOT EASILY BE REMOVED. THIS INDICATES THAT FAR TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED, WHICH FINALLY CAUSED THE BREAKAGE OF THE TIP. FURTHER INVESTIGATION REGARDING THE MANUFACTURING DOCUMENTS SHOW CONFORMITY TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER INSTRUMENT, PART NUMBER 314.152, WAS BROKEN OFF FROM THE SHAFT. IT WAS NOT REPORTED THAT THERE WAS ANY ILL EFFECT TOWARD THE PATIENT OR ANY INCREASE IN SURGERY TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290085 SCRDRIVERSHAFT-3.5-HEX SELF-HOLD HXX SYNTHES GMBH 2095025

    Patients

    Seq Age Sex Outcome Treatment
    1