BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL INTRAFX SHTH SCRSYS7MM

    MDR report key: 7671634 · Received July 9, 2018

    Report

    Report Number
    1221934-2018-51048
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705013616
    PMA / PMN Number
    K150209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED 2 DISSIMILAR 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. 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. UDI: (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

    IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL REPAIR THAT THE PROXIMAL TIP OF THE SCREW OF HIS INTRAFIX FEMORAL SHEATH AND SCREW SET BROKE UPON INSERTION. THE SALES REP REPORTED THAT THE SURGEON WAS NOT OFF AXIS BUT WAS FORCEFUL WHEN IMPLANTING SCREW. THE SALES REP REPORTED THAT THE SURGEON PREPPED THE HOLE AND USED A DILATOR. THE SURGEON COMPLETELY REMOVED THE 1ST ANCHOR AND USED THE SAME BONE HOLE FOR THE 2ND ANCHOR. THE SURGEON AUGMENTED THE TUNNEL SIZE TO 10.5MM AND USED A BIGGER GRAFT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP STATED THE PATIENT WAS A (B)(6) MALE OF AVERAGE WEIGHT. THE BONE QUALITY WAS AVERAGE. THE SALES REP HAD NO KNOWLEDGE OF THE PATIENT'S MEDICATIONS OR PREEXISTING CONDITIONS. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511077 FEMORAL INTRAFX SHTH SCRSYS7MM ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE MAI DEPUY MITEK LLC US 3438966 10886705013616

    Patients

    Seq Age Sex Outcome Treatment
    1