BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPUS SPEEDSCREW IMPLANT

    MDR report key: 9748469 · Received February 24, 2020

    Report

    Report Number
    3006524618-2020-00077
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    January 17, 2020
    Report Date
    May 19, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HWC
    UDI-DI
    00817470005196
    PMA / PMN Number
    K081893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. A REVIEW OF MANUFACTURING RECORDS FOR THIS LOT 2040197 FOUND NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE PRODUCT/PRINT SPECIFICATIONS FOUND NO DISCREPANCIES. WITHOUT THE REPORTED PRODUCT A VISUAL INSPECTION AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER´S COMPLAINT CANNOT BE CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE COMPLAINT INCLUDE, BUT ARE NOT LIMITED TO: 1- NOT ADHERE TO THE CORRESPONDING IFU 2- THERE MAY HAVE BEEN MISALIGNMENT OF THE DEVICE WHEN INSERTING 3- APPLYING EXCESSIVE TORQUE COULD CAUSE REDUCED FUNCTIONALITY THERE ARE NO INDICATIONS THAT SUGGEST THAT THE DEVICE DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CUFF REPAIR PROCEDURE, DURING THE IMPLANTATION OF THE ANCHOR, WHEN THE ANCHOR WAS RELEASED, IT WAS REPORTED THAT THE ANCHOR BROKE AT THE THREADS AND WAS EXPELLED FROM THE BONE. ANCHOR RE-IMPLANTATION WAS NOT PERFORMED DUE TO THE THREADS IN THE FIRST ROW HAD TO BE CUT TO REMOVE THE BROKEN ANCHOR. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209104 OPUS SPEEDSCREW IMPLANT SCREW, FIXATION, BONE HWC ARTHROCARE CORP. OM-6500 2040197 00817470005196

    Patients

    Seq Age Sex Outcome Treatment
    1