BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO INSCR SMALL SIZE 5X30

    MDR report key: 8133146 · Received December 5, 2018

    Report

    Report Number
    1221934-2018-55540
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 29, 2018
    Report Date
    December 1, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010721
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER THEREFORE THE DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT IS NOT CONFIRMED. WITHOUT PHYSICALLY EVALUATING THE DEVICE, A DEFINITE ROOT CAUSE CANNOT BE DETERMINED. NON CONFORMANCE REVIEW WAS PERFORMED, NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART NUMBER (231804), LOT NUMBER (L630312) COMBINATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. 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 THAT DURING A MEDIAL PATELLA FEMORAL LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5X30MM MILAGRO SCREW DEVICE BROKE IN HALF. THE SALES REP STATED THEY WERE ATTEMPTING TO FIXATE THE GRAFT WHEN THE SCREW BROKE. THE SALES REP STATED THAT HALF OF THE SCREW WAS RECOVERED BY USING A DRIVER AND THE REMAINING HALF WAS LEFT IN THE BONE FOR FIXATION. THE CASE WAS COMPLETED WITH HALF OF THE SCREW WITH NO PATIENT HARM OR DELAY. THE REMOVED HALF OF THE SCREW WAS DISCARDED BY THE CUSTOMER. THE SALES REP REPORTED THAT ADDITIONAL SCREWS WERE USED BUT NO ADDITIONAL BONE HOLE HAD TO BE CREATED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    973137 MILAGRO INSCR SMALL SIZE 5X30 ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK LLC US L630312 10886705010721

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR