BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5HLX ADV PK ANC-DYNA STR/BL

    MDR report key: 8074996 · Received November 15, 2018

    Report

    Report Number
    1221934-2018-55324
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    November 2, 2018
    Report Date
    November 2, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705029426
    PMA / PMN Number
    K173859
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4). INVESTIGATION SUMMARY: THE DEVICE IS NOT BEING RETURNED. THE DEVICE IS NOT AVAILABLE FOR PHYSICAL EVALUATION AND HENCE THIS COMPLAINT CANNOT BE CONFIRMED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (222028), LOT NUMBER (L973673) COMBINATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SALES REP'S 4.5MM HEALIX ADVANCE PEEK ANCHOR WITH DYNACORD BROKE AFTER INSERTION. THE SALES REP STATED THE ANCHOR IS BROKEN IN THE MIDDLE OF THE ANCHOR. THE SALES REP STATED THE ISSUE MIGHT HAVE OCCURRED BECAUSE IT WAS OFF AXIS DURING INSERTION. THE SALES REP STATED THE ANCHOR WAS REMOVED BY PULLING ON THE DRIVER AND THE SUTURES TO REMOVE THE WHOLE ANCHOR WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED BY USING ANOTHER ANCHOR IN A NEW BONE HOLE WITH NO TIME DELAY. THE SALES REP STATED THERE IS NO NEED FOR SURGICAL INTERVENTION. THE ANCHOR WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914762 4.5HLX ADV PK ANC-DYNA STR/BL SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE MBI MEDOS INTERNATIONAL SàRL L973673 10886705029426

    Patients

    Seq Age Sex Outcome Treatment
    1