BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX 5.0MM ANCHOR W/ULTRABRAID AND NEEDLES

    MDR report key: 1341508 · Received January 5, 2009

    Report

    Report Number
    1219602-2008-00270
    Event Type
    Malfunction
    Date Received
    January 5, 2009
    Date of Event
    December 2, 2008
    Report Date
    December 3, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE ANCHOR EYELET IS CONSISTENT WITH EXCESSIVE FORCE PLACED ON THE DEVICE DURING INSERTION. SURGEON DID NOT PRE-DRILL WHICH IS REQUIRED PER THE IFU.

    Description of Event or Problem · 1

    DURING A ROTATOR CUFF REPAIR, THE SURGEON TAPPED THE BONE WITH A 2.5 ARTHREX DILATOR AND WHEN THE ANCHOR WAS ALMOST COMPLETELY INSERTED, THE TOP OF THE ANCHOR SNAPPED OFF. BONE WAS CLEARED AROUND THE ANCHOR AND THE ANCHOR WAS REMOVED FROM THE JOINT. ADDITIONAL DEVICE WAS AVAILABLE TO COMPLETE THE REPAIR. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX 5.0MM ANCHOR W/ULTRABRAID AND NEEDLES TWINFIX 5.0MM ANCHOR MBI SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7210708 50249237

    Patients

    Seq Age Sex Outcome Treatment
    1