BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILAGRO ADVANCE SCREW, 8X30MM

    MDR report key: 7685626 · Received July 13, 2018

    Report

    Report Number
    1221934-2018-52650
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    UDI-DI
    10886705022267
    PMA / PMN Number
    K123362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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. EVALUATION STATEMENT: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH AN UNRELATED (B)(4) TO THE REPORTED INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF 400 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. HOWEVER, DEPUY 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. (B)(4). THIS REPORT IS BEING FILED FROM THE REMETREX COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SURGEON HAD DIFFICULTY INSERTING THE SCREW ( PRODUCT CODE 231816) DEVICE INTO THE BONE HOLE ON THE FEMORAL SIDE SINCE THE RATCHET HANDLE OF THE DRIVER DID NOT WORK WELL. WHEN INSERTED A LITTLE, THE TIP OF THE SCREW DEVICE BROKE AND WAS LEFT IN THE BONE HOLE. THE SURGEON HAD CRUSHED THE BROKEN TIP IN THE BONE HOLE WITH THE DILATOR AND ANOTHER SCREW WAS INSERTED. FOR THE TIBIAL SIDE, THE SCREW DEVICE (PRODUCT CODE 231821) WAS USED AND IT WAS ALSO HARD TO INSERT WITH THE SAME DRIVER. WHEN FULLY INSERTED, THE SCREW WAS FOUND BROKEN IN THE BONE HOLE BY CHECKING WITH 1.1MM GUIDE PIN. THE BROKEN SCREW WAS REMOVED. DUE TO THE INCIDENT, THE PROCEDURE WAS EXTENDED FOR 30 MINUTES. THE PRODUCTS WERE DISCARDED AT THE HOSPITAL. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE. 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
    528726 MILAGRO ADVANCE SCREW, 8X30MM ORTHOPAEDIC BONE SCREW, BIOABSORBABLE HWC DEPUY MITEK 3710000 10886705022267

    Patients

    Seq Age Sex Outcome Treatment
    1