BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXOSHAPE SOFT TISSUE FASTENER

    MDR report key: 8226834 · Received January 8, 2019

    Report

    Report Number
    1017294-2018-00193
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    December 10, 2018
    Report Date
    January 8, 2019
    Manufacturer
    MEDSHAPE INC.
    Product Code
    MBI
    PMA / PMN Number
    K111471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED, USED IMPLANT FOUND A CRACK THROUGH THE MAIN BODY WHICH ALLOWED THE TWO PIECES TO SEPARATE. THE MOST LIKELY CAUSE OF THIS TYPE OF FAILURE IS THE USE OF EXCESSIVE FORCE. HOWEVER, THE CUSTOMER ONLY RETURNED FOR THE EVALUATION THE IMPLANT, THE GUN USED TO DEPLOY THE IMPLANT WAS NOT RETURNED FOR THE EVALUATION. THE MANUFACTURING DOCUMENTS FOR THE DEVICE HISTORY RECORD WERE REQUESTED FROM MEDSHAPE FOR THIS LOT OF PRODUCT; HOWEVER, TO DATE NO DETAILS HAVE BEEN PROVIDED. THERE HAVE BEEN NO OTHER SIMILAR REPORTS FOR THIS DEVICE AND LOT COMBINATION PER A TWO-YEAR REVIEW OF COMPLAINT HISTORY. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 1 COMPLAINT, REGARDING 1 DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED THE RATE OF FAILURE WOULD BE (B)(4). THE USER IS ADVISED THE FOLLOWING; (B)(6) ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE (B)(6) REPRESENTATIVE REPORTED THAT THE 1600-00-009, EXOSHAPE IMPLANT, WAS BEING USED IN AN ACL SURGERY ON (B)(6) 2018. THE IMPLANT CRACKED AND THEREFORE THE WINGS OF IMPLANT WOULD NOT DEPLOY. THE SURGICAL TEAM WAS ABLE TO REMOVE THE IMPLANT COMPLETELY AND USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE SURGERY. THERE WAS A 5-MINUTE DELAY TO EXCHANGE THE DEVICES. THERE WAS NO REPORTED PATIENT INJURY. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21681 EXOSHAPE SOFT TISSUE FASTENER SOFT TISSUE FASTENER MBI MEDSHAPE INC. 02492

    Patients

    Seq Age Sex Outcome Treatment
    1