BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXTRA HAMMERTOE CORRECTION SYSTEM

    MDR report key: 8422053 · Received March 14, 2019

    Report

    Report Number
    3009540749-2019-00002
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 4, 2019
    Report Date
    February 15, 2019
    Manufacturer
    NEXTREMITY SOLUTIONS, INC.
    Product Code
    HWC
    UDI-DI
    00817701020059
    PMA / PMN Number
    K110445
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROXIMAL SCREW USED IN THE (B)(6) 2019 SURGERY REMAINED IMPLANTED AND WAS SUCCESSFULLY USED WITH A REPLACEMENT MIDDLE IMPLANT ON (B)(6) 2019. SUCCESSFUL USAGE OF THE ORIGINAL PROXIMAL SCREW WITH A SECOND MIDDLE IMPLANT INDICATES THE DISLOCATION WAS NOT A RESULT OF A DEFECT WITH THE PROXIMAL SCREW. THE SUSPECT MIDDLE SCREW RETURNED TO NEXTREMITY SOLUTIONS INC. WAS VISUALLY REVIEWED AND FUNCTIONALLY TESTED WITH A PROXIMAL SCREW, THE SAME PART NUMBER USED IN THE (B)(6) 2019 SURGERY. THE MIDDLE AND PROXIMAL IMPLANTS LOCKED TOGETHER AS DESIGNED AND INTENDED. THE FUNCTIONAL REVIEW REVEALED NO DEFECT WITH THE MIDDLE SCREW. THE DEVICE HISTORY RECORD FOR THE SUSPECT MIDDLE IMPLANT LOT WAS REVIEWED. THE DEVICE HISTORY RECORD REVEALED THAT APPROPRIATE INSPECTION WAS COMPLETED WHICH VERIFIED THE MIDDLE SCREWS MET PRINT AND THAT THE PRODUCT WAS MADE FROM COMPLIANT MATERIALS AND CONFORMED TO ALL SPECIFICATIONS. DEVICE HISTORY RECORDS FOR ALL KITS WHICH ARE COMPOSED OF THE SUSPECT LOT OF MIDDLE SCREWS WERE ALSO REVIEWED AND FOUND TO MEET NEXTREMITY SOLUTIONS INC.'S RECEIVING INSPECTION. NEXTREMITY SOLUTIONS INC.'S COMPLAINT HISTORY WAS REVIEWED FOR IDENTIFICATION OF TRENDS. THERE ARE NO OTHER COMPLAINTS FOR THE SPECIFIC LOTS INVOLVED IN (B)(4). COMPLAINTS INVOLVING KITS CONTAINING MIDDLE SCREWS WERE REVIEWED TO DETERMINE IF THERE IS A TREND FOR DISLOCATED NEXTRA DEVICES INVOLVING THE MIDDLE SCREW. THERE WERE ZERO OTHER COMPLAINTS WHICH REPORTED DISLOCATION DUE TO MIDDLE SCREWS. THERE ARE NO TRENDS IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORDS, REVIEW PREVIOUS COMPLAINTS, AND THE PASSED FUNCTIONAL TEST OF THE SUSPECT MIDDLE SCREW INDICATES THE DISLOCATION WAS NOT A RESULT OF A DEFECT WITH THE MIDDLE SCREW.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT HAMMERTOE SURGERY ON (B)(6) 2019. AFTER SURGERY, X-RAYS SHOWED THE IMPLANT HAD DISLOCATED. THE PATIENT CAME BACK INTO THE DOCTOR'S OFFICE THE FOLLOWING DAY FOR THE SURGEON TO ATTEMPT TO FIX THE DISLOCATION. THIS WAS NOT SUCCESSFUL. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2019, AT WHICH POINT THE SURGEON REMOVED THE DISLOCATED 3.5MM MIDDLE IMPLANT. THE SURGEON IMPLANTED A 4.5 MIDDLE IMPLANT TO REPLACE THE IMPLANT. THIS WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214714 NEXTRA HAMMERTOE CORRECTION SYSTEM PHALANX BONE SCREW IMPLANT HWC NEXTREMITY SOLUTIONS, INC. NX-3532K-SC 168110917B 00817701020059

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other