BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHRO PIERCE 45 DEGREE LEFT

    MDR report key: 1112735 · Received August 11, 2008

    Report

    Report Number
    1219602-2008-00192
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 7, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE DEVICE SHOWED THE MOVABLE JAW HAS BROKEN. A SMALL PORTION OF THE JAW REMAINS ATTACHED TO THE SHAFT AND ACTUATOR. THE DISTAL TIP IS BENT SLIGHTLY. DEVICE HAS BEEN FORWARDED TO QUALITY ENGINEER FOR FURTHER EVAL OF THE ROOT CAUSE.

    Description of Event or Problem · 1

    DURING A SHOULDER STABILIZATION AND SLAP REPAIR, A SMALL PIECE OF METAL BROKE FROM THE END OF THE ARTHROPIERCE WHEN TRYING TO PASS THE ANCHOR SUTURE. HINGED PART FROM THE TIP BROKE OFF. SURGEON WAS UNABLE TO FIND FRAGMENT, EITHER EMBEDDED IN SOFT TISSUE OR WASHED OUT. A COMPETITOR DEVICE WAS USED TO COMPLETE THE SUTURING. NO PT INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHRO PIERCE 45 DEGREE LEFT ARTHRO PIERCE HRX SMITH & NEPHEW INC., ENDOSCOPY DIV. 7209498 LT307

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR