BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR KNOTLESS

    MDR report key: 3864231 · Received June 10, 2014

    Report

    Report Number
    1219602-2014-00175
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    PMA / PMN Number
    K093428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE BIORAPTOR KNOTLESS SUTURE ANCHOR INSERTER WAS RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED, THE DISTAL END OF THE INNER SHAFT HAS BROKEN OFF. IT APPEARS TO HAVE TWISTED DURING ADVANCEMENT OF THE INNER PLUG OF THE ANCHOR AND THEN ULTIMATELY FAILED DUE TO TORSIONAL OVERLOAD. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURE OF THIS LOT. BASED ON THE CONFIRMATION OF THE FAILURE, A CORRECTIVE ACTION REQUEST IS BEING ISSUED. (B)(4).

    Description of Event or Problem · 1

    DURING A HIP ARTHROSCOPY UTILIZING A BIORAPTOR KNOTLESS SUTURE ANCHOR, HIP, IT WAS REPORTED THAT THE TIP OF THE METAL INSERTER BROKE. THE BONE HOLE AND PREP WAS COMPLETED WITH A 2.9 BIORAPTOR DRILL. NEXT, THE SURGEON PROCEEDED TO TAP IN THE ANCHOR. THE INSERTER TIP SNAPPED OFF DURING INSERTION AND REMAINS IN THE ANCHOR. THE ANCHOR WITH THE BROKEN INSERTER TIP WAS NOT REMOVED FROM THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338536 BIORAPTOR KNOTLESS BIORAPTOR KNOTLESS SUTURE ANCHOR, HIP MBI MANSFIELD MANUFACTURING SITE 72202397 50485978

    Patients

    Seq Age Sex Outcome Treatment
    1