BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 X 30MM MILAGRO INTERFERENCE SCREW

    MDR report key: 8277956 · Received January 25, 2019

    Report

    Report Number
    1221934-2018-51385
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    March 18, 2016
    Report Date
    March 21, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705010837
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4). THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. MISSING DATA FROM INVESTIGATION AND COMPLETE UDI PROVIDED: A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PART#: 231840 LOT#:3706180 COMBINATION AND NO NONCONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. 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 THAT DURING AN ACL REPAIR THAT THE THREADS ON THE CUSTOMER'S MILAGRO INTERFERENCE SCREW 10 X 30MM BECAME DAMAGED WHEN THE SCREW WAS BEING INSERTED INTO THE BONE TUNNEL. IT WAS REPORTED THAT DURING USE THE SURGEON DID NOT NOTCH AND THE TUNNEL WAS TOO TIGHT CAUSING TO THE SCREW TO BREAK WHEN FULLY INSERTED. THE SURGEON REMOVED THE SCREW LEAVING NOTHING IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SAME TYPE SCREW IN THE SAME BONE TUNNEL WITH NO PATIENT CONSEQUENCES OR DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70343 10 X 30MM MILAGRO INTERFERENCE SCREW ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK LLC US 3706180 10886705010837

    Patients

    Seq Age Sex Outcome Treatment
    1