BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS, WRENCH

    MDR report key: 2760732 · Received September 20, 2012

    Report

    Report Number
    8030965-2012-00890
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 25, 2012
    Report Date
    August 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE CENTERING SHAFT WAS ABLE TO MATE WITH THE SUPPLIED DHS LAG SCREW, HOWEVER THE DHS/DCS INSERTION WRENCH WAS NOT ABLE TO FIT OVER THE DHS LAG SCREW. THE LAG SCREW HAS A LARGER DIAMETER AND WIDTH, COMPARED TO THE CENTERING SHAFT, SO THE INSERTION WRENCH WILL ENGAGE AND DRIVE IT INTO THE FEMORAL NECK AND HEAD. IN ORDER FOR THE TANGS ON THE CENTERING SLEEVE TO BE DEFORMED (CLOCK-WISE DIRECTION), MISUSE OF THE INSTRUMENTATION HAD TO OCCUR. THE INSERTION WRENCH MOST LIKELY WAS NOT FULLY SEATED ONTO THE LAG SCREW AND THE USER PROCEEDED TO APPLY TORQUE FOR INSERTION WHICH LED TO THE DEFORMATION OF THE TANGS ON THE CENTERING SHAFT ALONG WITH THE LATERAL END OF THE DHS LAG SCREW. THIS CAUSED THE CONDITION OF THE DHS/DCS INSERTION WRENCH NOT ENGAGING ONTO THE DHS LAG SCREW.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS LOST DURING TRANSPORTATION. WITHOUT THE PART, NO MANUFACTURING EVALUATION IS POSSIBLE. THE PICTURE OF THE RETURNED DEVICE SHOWS THAT THERE IS NO LOT NUMBER MARKED ON THE DEVICE. THIS IS AN INDICATION THAT THE WRENCH WAS MANUFACTURED BEFORE 1995, THEREFORE, THE DEVICE WAS USED OVER YEARS.(B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    DURING A PROCEDURE TO REPAIR AN INTERTROCHANTERIC FRACTURE RESULTING FROM AN INJURY ON (B)(6) 2012, IT WAS REPORTED THAT THE TABS ON THE COUPLING WERE BENT. WHEN USED WITH THE LAG SCREW, THE SCREW WOULD NOT SEAT WITH THE PLATE. THE SURGEON REMOVED THE LAG SCREW THEN INSERTED A NEW DHS LAG SCREW USING THE SAME PLATE, AND USING A DIFFERENT INSERTER. THE SURGEON WAS NOT ABLE TO USE THE ORIGINAL LAG SCREW BECAUSE HE COULD NOT GET THE ORIGINAL LAG SCREW TO COUPLE PROPERLY AFTER INITIAL INSERTION. THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. SURGERY WAS EXTENDED BY APPROXIMATELY 5-10 MINUTES. NO ADVERSE EFFECT TO THE PATIENT WAS NOTED. THERE WAS NO REPORTED COMPLAINT WITH PLATE USED. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DHS/DCS, WRENCH DHS/DCS, WRENCH HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR GUIDE SHAFT WITH FLATS| LAG SCREW