BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP UNI ANTERIOR CHISEL

    MDR report key: 6174458 · Received December 14, 2016

    Report

    Report Number
    1818910-2016-33445
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    December 6, 2016
    Report Date
    January 13, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    FZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH AGAINST THE PROVIDED PRODUCT CODE FOUND ADDITIONAL REPORTS OF BLADE BREAKAGE. PREVIOUS INVESTIGATIONS OF BLADE TIP DAMAGE/BREAKAGE FOUND EVIDENCE INDICATING THE BLADE TIP MADE CONTACT WITH THE CUTTING BLOCK FIXATION PINS. THE SIGMA PARTIAL KNEE UNICONDYLAR SURGICAL TECHNIQUE STATES " THE CHISEL IS REQUIRED ONLY IN THE TRACK CLOSEST TO THE PATELLA. FOR KNEES THAT DO NOT ACHIEVE ADEQUATE FIXATION WITH THE OUTBOUND PINS, AN ADDITIONAL PIN CAN BE PLACED PROXIMALLY. PIN THE HOLE FARTHEST AWAY FROM THE PATELLA AND USE THE ANTERIOR CHISEL IN THE TRACK CLOSEST TO THE PIN. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE CURRENT REPORTED EVENT WITHOUT THE DEVICE TO EXAMINE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. MONITOR COMPLAINTS THROUGH (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4). FOLLOWUP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER, AND THE INFORMATION IS NOT AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE ANTERIOR CHISEL SNAPPED INSIDE THE SIZE 5 FEMORAL FINISHING BLOCK DURING AN OPERATION. THE SURGEON WAS ABLE TO CONTINUE WITH THE SURGERY WITHOUT ANY HARM TO THE PATIENT BUT STRUGGLED TO REMOVE THE CHISEL FROM THE BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824081 SIGMA HP UNI ANTERIOR CHISEL KNEE INSTRUMENT/TRIAL FZO DEPUY ORTHOPAEDICS, INC. PG244705

    Patients

    Seq Age Sex Outcome Treatment
    1