BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VHS VARI-ANGLE PLATE - 4 HOLE

    MDR report key: 6214413 · Received December 29, 2016

    Report

    Report Number
    0001825034-2016-05417
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    July 7, 2016
    Report Date
    May 14, 2018
    Manufacturer
    BIOMET TRAUMA
    Product Code
    KTT
    PMA / PMN Number
    PK964880
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. UNKNOWN DATE IN (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THAT WHITE DEBRIS IS FOUND INSIDE THE STERILE PACKAGING. FTIR ANALYSIS CONDUCTED ON THE WHITE DEBRIS IDENTIFIED THAT IT IS CONSISTENT WITH THE ADHESIVE USED IN THE PACKAGING PROCESS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW WITH THE PACKAGING TEAM IDENTIFIED THAT THE DEBRIS FOUND IS CONSISTENT WITH ADHESIVE USED IN PACKAGING. THERE IS EVIDENCE OF ABRASION CAUSED BY THE FOAM POUCH TO THE TYVEK LIDSTOCK, CAUSING THE ADHESIVE COATING TO BE TRANSFERRED ONTO THE TRAY. THIS IS A COMMON PHENOMENON CAUSED DURING TRANSIT AND DOES NOT CAUSE ANY RISK TO THE PATIENT SINCE ALL THE CONTACT PACKAGING ARE MADE OF BIOCOMPATIBLE MATERIALS. THE ROOT CAUSE FOR THE REPORTED ISSUE IS ATTRIBUTED TO TRANSIT DAMAGE. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PRODUCT WAS NOTED TO BE COVERED IN A WHITE RESIDUE. THERE WAS NO PATIENT INJURY OR DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862709 VHS VARI-ANGLE PLATE - 4 HOLE APPLIANCE, FIXATION KTT BIOMET TRAUMA N/A 586600

    Patients

    Seq Age Sex Outcome Treatment
    1