BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA HP UNI ANTERIOR CHISEL

    MDR report key: 5124404 · Received October 2, 2015

    Report

    Report Number
    1818910-2015-32009
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 24, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS FOR MDR: EXAMINATION OF THE SUBMITTED SIGMA HP UNI ANTERIOR CHISEL CONFIRMED THE CHISEL BLADE IS BROKEN INTO TWO SECTIONS. THERE IS DAMAGE TO THE BLADE TIP INDICATING REPEATED CONTACT WITH THE CUTTING BLOCK FIXATION PINS. THE TIP DAMAGE IS DUE A PIN BEING PRESENT IN THE TRACK CLOSEST TO THE PATELLA WHILE CHISELING. THE SURGICAL TECHNIQUE STATES " THE CHISEL IS REQUIRED ONLY IN THE TRACK CLOSEST TO THE PATELLA. PIN THE HOLE FARTHEST AWAY FROM THE PATELLA AND USE THE ANTERIOR CHISEL IN THE TRACK CLOSEST TO THE PIN. THE ROOT CAUSE IS USER ERROR. BASED ON THE SURGICAL TECHNIQUE NOTING THE RECOMMENDED PIN LOCATION WHILE USING THE CHISEL, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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. (B)(4).

    Description of Event or Problem · 1

    WHILE TAPPING IN CHISEL INTO FEMORAL CUT GUIDE THE CHISEL BROKE IN TWO PIECES. NO SURGICAL DELAY OCCURRED AND NO PIECE OF INSTRUMENTATION WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654818 SIGMA HP UNI ANTERIOR CHISEL KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. PG1009

    Patients

    Seq Age Sex Outcome Treatment
    1