BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO ADVANCE SCREW 9X30MM

    MDR report key: 7869640 · Received September 12, 2018

    Report

    Report Number
    1221934-2018-54635
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 21, 2018
    Report Date
    August 21, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705022274
    PMA / PMN Number
    K123362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEALED THE REMNANTS OF THE DEVICE SPLIT IN HALF. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED. THE INFORMATION PROVIDED STATED THAT THE SURGEON WAS NOT OFF AXIS AND THE PATIENT HAD STANDARD BONE QUALITY. WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE, HOWEVER, IF THERE WAS A POSSIBILITY THAT THE BONE HOLE WAS NOT PREPARED PROPERLY, THIS COULD CAUSE THE FAILURE. FURTHERMORE, A NONCONFORMANCE SEARCH WAS CONDUCTED AND NO NONCONFORMANCES HAVE BEEN IDENTIFIED FOR THIS PART 231822 WITH LOT L926609. AT THIS POINT, 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. UDI: (B)(4). ASSOCIATED MEDWATCH REPORT NUMBER: 1221934-2018-54634.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). ASSOCIATED MEDWATCH: 1221934-2018-54634.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING ACL PROCEDURE TWO MILAGRO INTERFERENCE SCREWS BROKE INTRAOPERATIVELY WHILE SCREWING IN AND THERE WAS NO PATIENT HARM INDICATED. ADDITIONAL INFORMATION FROM AFFILIATE 8/29/2018: THE UPPER PART OF THE IMPLANT BROKE. THE PATIENT¿S BONE QUALITY WAS STANDARD. NO INFORMATION ON HOW THE CASE WAS COMPLETED. NO SURGICAL DELAY. THE SURGEON/DOCTOR WAS NOT OFF AXIS. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. IMPLANT WAS REMOVED AND NO DEBRIS WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709396 MILAGRO ADVANCE SCREW 9X30MM ORTHOPAEDIC BONE SCREW, BIOABSORBABLE HWC DEPUY MITEK LLC US L926609 10886705022274

    Patients

    Seq Age Sex Outcome Treatment
    1