BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO ADVANCE SCREW 8X30MM

    MDR report key: 10099397 · Received May 28, 2020

    Report

    Report Number
    1221934-2020-01461
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 14, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    PMA / PMN Number
    K123362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION: B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DISTRIBUTOR AND THE DOCTOR REFUSED THE COMPLAINT. THEY CONSIDERED THAT THE BREAKAGE OF THE SCREW WAS MINOR AND DIDN'T APPEAR ON THE RESULT OF THE OPERATION. IT WAS REPORTED THAT THE PROCEDURE WSA COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY NOR HARM TO THE PATIENT. D1, D4, G1-G2, G5: THE PRODUCT CODE HAS BEEN UPDATED AS 231821; THEREFORE, THE BRAND NAME, CATALOG, UDI, MANUFACTURING SITE NAME, MANUFACTURING SITE ADDRESS, MANUFACTURING SITE EMAIL ADDRESS AND 510(K) HAVE ALL BEEN UPDATED ACCORDINGLY. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ==> THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. FURTHER, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. ADDITIONAL NARRATIVE: UDI: UNAVAILABLE. THE UDI IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AFFILIATE VIA EMAIL THAT DURING AN ACL PROCEDURE, WHILE USING MILAGRO ADVANCE SCREW, IT HAD FRACTURED IN THE FEMORAL TUNNEL. THE LIGAMENT HAD BEEN 8.5 MM, THE TUNNEL 9 MM, THE SCREW FOR FEMORAL FIXATION 8 MM, SCREW FOR TIBIAL FIXATION 9 MM. THE SCREW HAD SCREWED INTO THE TIBIUM PERFECTLY, BUT IN THE FEMUR THE SCREW HAD ENTERED FOR THE 2/3 IN THE CHANNEL AND THEN IT HAD BROKEN IN HALF ALONG THE AXIS. THE DOCTOR DISCARDED THE DEVICE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560835 MILAGRO ADVANCE SCREW 8X30MM ORTHOPAEDIC BONE SCREW, BIOABSORBABLE HWC DEPUY MITEK LLC US UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1