BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR KNOTLESS SUTURE ANCHOR

    MDR report key: 2990043 · Received March 5, 2013

    Report

    Report Number
    1219602-2013-00056
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 9, 2013
    Manufacturer
    SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SURGEON HAD A SITUATION WITH 2 SEPARATE ANCHORS WHEREBY, WHEN HE TRIED TO INSERT THE ANCHOR INTO THE HOLE HE HAD DRILLED THE INSERTER BUCKLED AT THE JUNCTION BETWEEN THE ANCHOR AND THE INSERTER. THE INNER PIN THAT SCREWS DOWN THE GRUB SCREW INSIDE THE ANCHOR WAS BENT IN THE PROCESS RENDERING THE ANCHOR UNUSABLE. ACCORDING TO THE SALES REP, IT IS POSSIBLE THAT THE SURGEON DIDN'T HAVE THE ANCHOR FULLY IN THE HOLE AND THIS IMPACT AGAINST BONE WAS WHAT CAUSED THE ANCHOR TO FAIL. ADDITIONAL INFORMATION STATED THE ANCHORS BROKE UPON INSERTION AND WERE DISCARDED (NOT LEFT IN PLACE). IN SUMMARY A HOLE WAS DRILLED AND 2 DIFFERENT ANCHORS WERE DAMAGED WHEN THE SURGEON TRIED TO INSERT THEM INTO THIS HOLE. HE DECIDED TO DRILL A SECOND HOLE, INTO WHICH A 3RD ANCHOR WAS SUCCESSFULLY INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93962 BIORAPTOR KNOTLESS SUTURE ANCHOR BIORAPTOR KNOTLESS SUTURE ANCHOR, HIP MBI SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE 50438868

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR