BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS GUIDE SHAFT

    MDR report key: 2925922 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00191
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM RETURNED PRODUCT QUESTIONNAIRE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICES AND INDICATED THAT THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY AN OFF-AXIS FORCE BEING APPLIED TO THE RETURNED DHS/DCS COUPLING SCREW (PART#(B)(4)) WHICH CAUSED THE THREADED PORTION TO SHEAR OFF. THE COUPLING SCREW WAS MANUFACTURED IN AUGUST 2008 AND IS OVER 4 YEARS OLD. THE DEVICE IS MANUFACTURED FROM 17-4PH MATERIAL WHICH IS A TYPICAL MATERIAL SYNTHES USES TO MAKE CANNULATED COUPLING SCREWS. THE RETURNED DHS/DCS GUIDE SHAFT (PART #(B)(4)) WAS MANUFACTURED IN SEPTEMBER 1998 AND IS OVER 14 YEARS OLD. BASED ON THE AGE OF THE RETURNED DEVICE, THIS DEVICE HAS OUTLIVED ITS USEFUL LIFE. THE MANUFACTURE DATE OF RETURNED DHS/DCS LAG SCREW (PART #(B)(4)) WAS MANUFACTURED IN SEPTEMBER 2012. THE DEVICE IS MANUFACTURED FROM 316L SS WHICH IS A TYPICAL MATERIAL SYNTHES USES TO MAKE LAG SCREWS. THE COMPLAINT CONDITION WAS CAUSED BY AN OFF AXIS FORCE CAUSING THE THREAD TO FRACTURE AT THE LOCATION JUST ABOVE WHERE THE THREAD WAS SUPPORTED INSIDE THE RETURNED LAG SCREW. THE RISK ANALYSIS WAS REVIEWED AND IT DID NOT ADDRESS THE COMPLAINT CONDITION FOR THE THREADS SHEARING DUE TO OFF-AXIS FORCE. PRODUCT DEVELOPMENT WAS NOTIFIED TO UPDATE/RECREATE RISK ANALYSIS TO ADEQUATELY ADDRESS THESE COMPLAINT CONDITIONS. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT AVAILABLE AS THE DEVICE IS OLDER THAN 15 YEARS.

    Description of Event or Problem · 1

    DURING AN INTERTROCHANTERIC PROXIMAL FEMUR FRACTURE PROCEDURE USING DHS SYSTEM, SOME OF THE THREADS OF THE INSERTER BROKE OFF INTO THE LAG SCREW DURING INSERTION. ALL FRAGMENTS WERE REPORTEDLY RETRIEVED. THE SURGEON REMOVED THE LAG SCREW AND INSERTER, USED A DIFFERENT LAG SCREW AND INSERTER, AND COMPLETED THE PROCEDURE. THERE WAS NO EXTENSION OF SURGERY TIME. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28962 DHS/DCS GUIDE SHAFT DHS/DCS GUIDE SHAFT HXX SYNTHES GMBH 1034

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR COUPLING SCREW, LAG SCREW