BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMICAP RESURFACING SYSTEM - 2.0MM GUIDE PIN

    MDR report key: 7971220 · Received October 16, 2018

    Report

    Report Number
    3004154314-2018-00018
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    February 28, 2018
    Report Date
    September 24, 2018
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    LXH
    PMA / PMN Number
    K031859
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REP WHO ATTENDED THE CASE, A 2.0MM GUIDE PIN BROKE WHEN THE SURGEON WAS RE-REAMING THE BONE. THE SURGEON DECIDED TO LEAVE THE BROKEN GUIDE PIN FRAGMENT INSIDE THE BONE AFTER DETERMINING THAT IT WAS DIFFICULT TO RETRIEVE AND DID NOT PENETRATE OR PUNCTURE ANY CORTICAL SURFACE. THE SAME WAS CONVEYED TO THE PATIENT. THE DEVICE HISTORY RECORD OF THE LOT IN QUESTION WAS REVIEWED AND NOTED THAT ALL GUIDE PINS WERE BUILT TO SPECIFICATION. LIKEWISE, THE SALES HISTORY OF THE LOT WAS REVIEWED AND FOUND THAT NO OTHER COMPLAINTS OR ISSUES INDICATING FAILURE OR MALFUNCTION OF THE GUIDE PINS WERE REPORTED TO DATE. FOLLOWING A DISCUSSION WITH THE ENGINEERING DEPARTMENT AND A REVIEW OF SIMILAR COMPLAINTS FROM THE PAST INDICATED USE OF EXCESSIVE OR OFF-AXIAL FORCE TO BE THE CONTRIBUTING FACTORS OF THE REPORTED ISSUE. THE GUIDE PINS ARE GAMMA STERILIZED AND BUILT USING IMPLANT-GRADE MATERIAL (316LVM SST PER ASTM F138). HENCE, NO STERILITY OR BIOCOMPATIBILITY CONCERNS ARE EXPECTED. THERE IS NO DISCERNABLE EVIDENCE THAT THE GUIDE PIN MALFUNCTIONED DUE TO DEFICIENCIES IN THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED VIA A MEDWATCH REPORT FILED BY THE USER FACILITY CONCERNING A BROKEN GUIDE PIN DURING A TOE HEMIARTHROSPLASTY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810006 HEMICAP RESURFACING SYSTEM - 2.0MM GUIDE PIN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHROSURFACE, INC. 75AE0607

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other