BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS/DCS COUPLING SCREW

    MDR report key: 3055504 · Received April 12, 2013

    Report

    Report Number
    3003787298-2013-00060
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE THREADED DISTAL TIP ON BOTH RETURNED COUPLING SCREWS HAS FRACTURED MID THREAD. THE DISTAL TIP COMPLETELY SHEARED OFF OF ONE, AND IS BARELY RETAINED ON THE OTHER AND BENT AT AN ANGLE OF APPROXIMATELY 30 DEGREES. THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY AN OFF-AXIS FORCE BEING APPLIED TO THE RETURNED DHS/DCS COUPLING SCREWS (PART# (B)(4)) WHICH CAUSED THE THREADED PORTION TO SHEAR OFF. THE RETURNED COUPLING SCREWS WERE MANUFACTURED IN JANUARY 2012 (LOT# 6841030) AND SEPTEMBER 2012 (LOT# 7013095). THE DEVICE IS MANUFACTURED FROM (B)(4). THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 OF A LAG SCREW. AS A RESULT OF A PREVIOUS PRODUCT COMPLAINT, THE RISK ANALYSIS WAS REQUESTED FROM PRODUCT DEVELOPMENT. THE RECEIVED DOCUMENT ((B)(4)) DID NOT ADEQUATELY ADDRESS THE COMPLAINT CONDITION FOR THE THREADS SHEARING DUE TO OFF-AXIS FORCE. THEREFORE, PRODUCT DEVELOPMENT WAS NOTIFIED TO UPDATE/RECREATE RISK ANALYSIS TO ADEQUATELY ADDRESS THESE COMPLAINT CONDITIONS AS A RESULT OF THE PRIOR COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING AN ORIF OF THE HIP ON (B)(6) 2013, THE SURGEON WAS SCREWING THE HIPS SCREW TO THE FEMORAL NECK WHEN THE CONNECTING SCREW ON THE DHS/DCS COUPLING SCREW LOOSENED AND THE INSTRUMENT BROKE. A SECOND DHS/DCS COUPLING SCREW WAS USED FROM A DIFFERENT SET AND THE SAME ISSUE OCCURRED. SURGERY WAS DELAYED BY APPROXIMATELY 20 MINUTES, BUT THE SURGERY PROCEEDED WITH NO HARM TO THE PATIENT REPORTED. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159004 DHS/DCS COUPLING SCREW LXH SYNTHES JENNERSVILLE 6841030

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention