BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALICOIL PK 5.5MM W/ UB2-BL, UTP CBRD

    MDR report key: 5993688 · Received October 3, 2016

    Report

    Report Number
    1219602-2016-01131
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K113294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    VISUAL ASSESSMENT OF THE INSERTER CONFIRMED THE REPORTED COMPLAINT OF BREAKAGE. THE DISTAL TIP HAS BROKEN FROM THE SHAFT AT THE WELDMENT. EXAMINATION OF THE BREAK AREA SHOWS THE SHAFT IS SLIGHTLY SPLAYED. THE WELD APPEARS ADEQUATE ON BOTH THE TIP AND SHAFT. A REVIEW OF THE SHAFT COMPONENT USED TO MANUFACTURE THIS DEVICE LOT CONFIRMED THE SHAFTS WERE WELDED TO SPECIFICATION AND MET THE TEST REQUIREMENTS. AFTER THE EVALUATION THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE INSERTION SHAFT OF THE HEALICOIL ANCHOR BROKE OFF WHEN IT WAS PULLED OUT. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH THE USE OF A GRASPER. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THIS ANCHOR. THE MINIMAL PROCEDURAL IMPACT AND NO PATIENT IMPACT WAS NOTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645123 HEALICOIL PK 5.5MM W/ UB2-BL, UTP CBRD FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50548368

    Patients

    Seq Age Sex Outcome Treatment
    1