BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 3875173 · Received June 16, 2014

    Report

    Report Number
    2210968-2014-07695
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE OPERATED AS INTENDED DURING THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC INGUINAL HERNIA REPAIR ON (B)(6) 2014. ABSORBABLE STRAPS WERE USED TO SECURE THE MESH. THE SURGEON REPORTS THAT WHILE TRYING TO FIRE INTO THE COOPER'S LIGAMENT THE STRAP BROKE. THE LOCATION WAS CHANGED AND A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE SURGEON OPINES THAT HE MAY HAVE BEEN FIRING INTO BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352013 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. HCK416

    Patients

    Seq Age Sex Outcome Treatment
    1