BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HP MBT CEM KEEL PUNCH SZ 4-7

    MDR report key: 3894478 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21945
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF TAB BREAKAGE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE FRACTURES, HOWEVER HEAVY USAGE OVER TIME AND OR USER ERROR/MISUSE COULD BE CONTRIBUTING FACTORS. (B)(4) WAS PREVIOUSLY INITIATED TO IDENTIFY ROOT CAUSE AND ANY CORRECTIVE ACTIONS. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE TABS ON THE TOP OF THE SIGMA HP MBT KEEL PUNCH SZ 4-7 BROKE OFF DURING USE. THE BROKEN PIECES WERE RECOVERED CHECKED AGAINST THE PUNCH TO ENSURE NO PIECES WERE LEFT UNACCOUNTED FOR AND THEN THE BROKEN TAB WAS DISCARDED. THE SIGMA HP MBT KEEL PUNCH SZ 4-7 HAS BEEN DECONTAMINATED AND WILL BE RETURNED. PLEASE NOTE THAT THE BROKEN TAB WAS RECOVERED AND CHECKED AGAINST THE PUNCH TO ENSURE ALL PIECES WERE ACCOUNTED FOR TO ENSURE THERE WAS NO THIRD BODY METAL MATERIAL LEFT IN SITU. THE WOUND WAS THEN EXTENSIVELY IRRIGATED AND SUCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371149 HP MBT CEM KEEL PUNCH SZ 4-7 KNEE INSTRUMENT/TRIAL LXH DEPUY ORTHOPAEDICS, INC. J1108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other