BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENSIONER, BIOSURE SYNC

    MDR report key: 4935934 · Received July 23, 2015

    Report

    Report Number
    1219602-2015-00429
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    July 31, 2013
    Report Date
    July 23, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TENSIONER, BIOSURE SYNC WAS RETURNED FOR EVALUATION OF THE REPORTED COMPLAINT MODE "BROKEN TENSIONER". A VISUAL INSPECTION OF THE RETURNED DEVICE HAS CONFIRMED THAT THE PULLEY ASSEMBLY BLOCK FRACTURED, CAUSING IT TO SEPARATE FROM THE TENSIONER BODY. ROOT CAUSE FOR FRACTURE WAS FOUND TO BE INCONCLUSIVE. SMITH-NEPHEW WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. (B)(4).

    Description of Event or Problem · 1

    DURING AN ACL RECONSTRUCTION, A PIECE OF THE TENSIONER BROKE, PHYSICIAN UNABLE TO USE THE TENSIONER AND IT WAS REMOVED FROM THE SURGICAL TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481372 TENSIONER, BIOSURE SYNC ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1