BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX ULTRA PK 6.5MM SUTURE ANCHOR W/TWO ULTRABRAID (#2) SUTURES

    MDR report key: 4111377 · Received September 23, 2014

    Report

    Report Number
    1219602-2014-00282
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K112526
    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 DEVICE WAS RETURNED FOR EVALUATION. THE ANCHOR AND SUTURE WERE NOT RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED AND IT IS CONFIRMED THAT THE DRIVER SHAFT IS MISSING THE PORTION FROM THE DEPTH LASER MARK FORWARD. THE SITE OF THE BREAK IS JAGGED, AND THE MATERIAL IS DEFORMED. THE SITE OF THE BREAK IS APPEARS TO HAVE OCCURRED DUE TO A SIDE LOAD AS THE MATERIAL IS DEFORMED IN ONE DIRECTION. A REVIEW OF THE NONCONFORMANCE DATABASE DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURE OF THE DEVICE. THE ROOT CAUSE OF THE FAILURE CANNOT BE ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. DUE TO THE DEFORMATION OF THE SHAFT TIP AT THE BREAK SITE THE DEVICE WAS EXPOSED TO A SIDE LOAD THAT CAUSED THE MATERIAL TO FATIGUE AND FAIL. THE IFU CAUTIONS ¿USE OF EXCESSIVE FORCE DURING INSERTION CAN CAUSE FAILURE OF THE SUTURE ANCHOR OR INSERTION DEVICE. A TWO-FINGER AO TECHNIQUE SHOULD BE USED TO INSERT THE ANCHOR.¿ NO ADDITIONAL ACTION IS REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT YET BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON USED THE TWINFIX DILATOR TO PREP, THE HOLE AND THEN SCREWED THE ANCHOR INTO PLACE. AFTER THE ANCHOR WAS FULLY SEATED, THE SURGEON PULLED THE INSERTER OUT AND SAW THAT THE TIP HAD COME OFF AROUND THE EYELET OF THE ANCHOR. IT WAS REPORTED AFTER SEVERAL ATTEMPTS, THAT THE SURGEON COULD NOT REMOVE IT FROM THE PATIENT. THE TIP OF THE INSERTER REMAINS IN THE PATIENT AS IT WAS NOT PROTRUDING AND THE SURGEON THOUGHT IT WOULD NOT CAUSE ANY HARM TO THE REPAIR OR THE PATIENT. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590407 TWINFIX ULTRA PK 6.5MM SUTURE ANCHOR W/TWO ULTRABRAID (#2) SUTURES FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 72202630 50431223

    Patients

    Seq Age Sex Outcome Treatment
    1