BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILAGRO ADVANCE SCREW 7X23MM

    MDR report key: 8749245 · Received July 1, 2019

    Report

    Report Number
    1221934-2019-57496
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 4, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705022243
    PMA / PMN Number
    K143660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. THE HARD BONE OF THE PATIENT MIGHT HAVE CAUSED DIFFICULTY FOR THE SCREW TO ADVANCE, THEREFORE IS A POSSIBLE ROOT CAUSE. HOWEVER WITHOUT THE RETURN OF THE COMPLAINT DEVICE, AND NO FURTHER INFORMATION PROVIDED WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION PER QLIK QUERY EXECUTED ON 07/11/2019. 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. UDI: (B)(4).

    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. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED BY THE AFFILIATE REPORTED THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE 5MM SCREW WAS A DEPUY MITEK PRODUCT; PRODUCT CODE 213803 AND LOT NUMBER L982435. THE AFFILIATE REPORTED THE GUIDE WIRE AND STAPLE WERE COMPETITOR PRODUCTS AND THE PROCEDURE WAS COMPLETED WITH A STAPLE FROM DEVICE TECHNOLOGIES. IT WAS ALSO REPORTED A NEW BONE HOLE WAS NOT NEEDED TO COMPLETE THE CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA CST THAT THE SURGEON WAS DOING A 'LATERAL LOOP' RECONSTRUCTION FOR ROTATIONAL STABILITY AFTER COMPLETING AN ACL RECONSTRUCTION. THE SURGEON DRILLED A 4.5MM TUNNEL, WHICH HE PULLED THE GRAFT THROUGH, BEFORE INSERTING A 7MM MILAGRO ADVANCE SCREW. THE SCREW WOULD NOT ADVANCE INTO THE BONE, AND ON THE THIRD ATTEMPT, THE TIP OF THE SCREW BROKE OFF. THE SCREW FRAGMENT WAS EASILY REMOVED WITH A FORCEPS. A GUIDE-WIRE WAS USED. THE PATIENT HAD VERY HARD BONE IN THEIR FEMUR. THE SURGEON OPENED A 5MM SCREW, WHICH WOULD NOT ADVANCE EITHER. HE COMPLETED THE REPAIR USING A STAPLE. THERE WAS A SURGICAL DELAY OF TEN MINUTES REPORTED. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING A SMALLER SIZED IMPLANT AND EVENTUALLY A DIFFERENT TYPE OF IMPLANT. THERE WERE NO CONSEQUENCE TO THE PATIENT REPORTED. THERE WERE NO MEDICAL INTERVENTION REQUIRED. IT WAS ALSO NOTED THE ACTIVITY LEVEL OF THE PATIENT WAS HIGH IN SPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544170 MILAGRO ADVANCE SCREW 7X23MM ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK LLC US 2L06515 10886705022243

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR