BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIORAPTOR 2.9 WITH 1 ULTRABRAID

    MDR report key: 2862538 · Received December 10, 2012

    Report

    Report Number
    1219602-2012-00335
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DEVICES WERE RECEIVED FOR EVALUATION AS WELL AS TWO ANCHORS THAT WERE ALSO RETURNED. ONE ANCHOR WAS LOOSE IN THE RETURNED BAG, AND IT DID NOT APPEAR TO BE DAMAGED. THE DIAMETER OF THE RETURNED DEVICE WAS CONFIRMED TO BE 0.145", WITHIN PRINT SPECIFICATION. THE SECOND RETURNED ANCHOR WAS STILL ATTACHED TO THE SUTURE AND IT APPEARED TO BE BENT. A REVIEW OF THE INFORMATION PROVIDED BY THE COMPLAINANT IDENTIFIED THAT SITE WAS NOT PREPARED PRIOR TO INSERTION OF ANCHOR. PER IFU 10600304 WARNINGS "BREAKAGE OF THE SUTURE ANCHOR CAN OCCUR IF THE INSERTION SITE IS NOT PREPARED WITH THE RECOMMENDED SMITH & NEPHEW DRILL PRIOR TO IMPLANTATION". BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION PROVIDED BY THE COMPLAINANT, THE ROOT CAUSE OF THE DEVICE FAILURE MAY CONTRIBUTE TO USER DID NOT FOLLOW THE IFU. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY ISSUES IDENTIFIED DURING THE MANUFACTURE OF THIS DEVICE. A REVIEW OF THE COMPLAINTS DATABASE DID NOT IDENTIFY ANY COMPLAINTS ON FILE FOR THE REPORTED LOTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGICAL PROCEDURE, THE SURGEON WAS USING A BIORAPTOR 2.9 WITH 1 ULTRABRAID WHILE ATTEMPTING TO INSERT THE ANCHOR, THE ANCHOR BROKE OFF. ANOTHER ANCHOR WAS ATTEMPTED AND AGAIN THE ANCHOR BROKE. ADDITIONAL INFORMATION INDICATES "TUNNEL WAS DILATED, NO TAP OR STARTER WAS USED. THE DISTAL PORTION OF THE SCREW BROKE. A DRIVER WITH A LASER MARKED DEPTH GUIDE WAS USED. ALL PIECES WERE REMOVED WITH A GRASPER. PHYSICIAN IS CONFIDENT ALL PIECES WERE REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIORAPTOR 2.9 WITH 1 ULTRABRAID BIORAPTOR 2.9 WITH 1 ULTRABRAID MAI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72200774 50390494

    Patients

    Seq Age Sex Outcome Treatment
    1