BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEORAPTOR 2.3 W/ 1UB WHITE

    MDR report key: 3053069 · Received April 11, 2013

    Report

    Report Number
    1219602-2013-00087
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING HIP ATHROSCOPY AND LABRUM REPAIR, SURGEON INSERTED A 2.3MM OSTEORAPTOR ANCHOR INTO THE ACETABULUM FOR REPAIR OF THE LABRUM. AFTER PREPARING FOR THE ANCHOR WITH THE 2.3MM DILATOR HE ATTEMPTED TO INSERT THE FIRST ANCHOR. HE REMOVED THE ANCHOR BECAUSE HE WAS NOT HAPPY WITH THE SITE AND RE-ATTEMPTED TO INSERT THE ANCHOR, BUT THE ANCHOR LOST ITS FIXATION TO THE INSERTER HANDLE. WE THEN NOTICED THAT THE ANCHOR DID INDEED BREAK. WE OPENED A SECOND 2.3MM OSTEORAPTOR ANCHOR AND HE MANAGED TO INSERT THE ANCHOR, KNOT IT AND CUT THE SUTURE. HE CONTINUED TO DEBRIDE THE SITE AND FOUND A PIECE OF THE FIRST ANCHOR NEAR THE SITE, REMOVED IT AND CARRIED ON. THEN WE NOTICED A SECOND ANCHOR FRAGMENT THAT APPEARED NOT TO BELONG TO THE FIRST ANCHOR, BUT THE SECOND. AT THAT MOMENT HE RE-CHECKED THE STABILITY OF THE ANCHOR THAT WAS ALREADY INSERTED AND IT APPEARED TO BE STABLE AT THE TIME. HE REMOVED ALL VISIBLE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155914 OSTEORAPTOR 2.3 W/ 1UB WHITE OSTEORAPTOR 2.3 W/ 1UB WHITE MAI SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE 50433126

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR