BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD DISTAL FEMORAL CUT BLOCK ¿ FRICTION ATTACHMENT

    MDR report key: 4120661 · Received September 26, 2014

    Report

    Report Number
    0001825034-2014-07852
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    December 11, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS IS A SURGEON SPECIFIC INSTRUMENT THAT WAS PRODUCED WITHOUT A MAGNETIC CONNECTION (STANDARD CUT BLOCKS HAVE MAGNETIC CONNECTION). AS THIS IS SURGEON SPECIFIC, THIS WAS THE ONLY INSTRUMENT FOR THIS LOT THAT WAS DISTRIBUTED. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED IN LIKE NEW CONDITION AND MET PRINT SPECIFICATIONS BUT THE DESIGN WAS INCORRECT. IT WAS FOUND THAT THE COMBINATION OF THE TWO COMPONENTS RESULTED IN THE FEMORAL DISTAL RESECTION TO BE IN THE INCORRECT LOCATION. ALL FOUR SETS WERE CONTAINED AND THE DESIGN WAS CORRECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY UTILIZING A CUSTOM CUT BLOCK ON (B)(6) 2014. DURING THE PROCEDURE, THE CUSTOM CUT BLOCK WAS NOT MEASURING OR CUTTING ACCURATELY. A STANDARD CUT BLOCK WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. UPON INSPECTION, IT WAS ALLEGED THAT THERE WAS AN APPROXIMATELY 3MM DIFFERENCE BETWEEN THE CUSTOM CUT BLOCK AND THE STANDARD CUT BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600860 VANGUARD DISTAL FEMORAL CUT BLOCK ¿ FRICTION ATTACHMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET ORTHOPEDICS N/A RDWO 38018

    Patients

    Seq Age Sex Outcome Treatment
    1