BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PS HOUSING PUNCH

    MDR report key: 19768591 · Received July 18, 2024

    Report

    Report Number
    9681642-2024-00027
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    May 28, 2024
    Report Date
    July 12, 2024
    Manufacturer
    UNITED ORTHOPEDIC CORPORATION
    Product Code
    HWP
    UDI-DI
    04719872175537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THE COMPAINED INSTRUMENT HAS ALREADY REACHED THE PRODUCT LIFETIME DEFINED IN THE UNITED QUALITY MANUAL, AND THE INSTRUMENT HAS BEEN DISCARDED BY THE HOSPITAL ALREADY, THE SUBSEQUENT ANALYSIS CANNOT BE CARRIED OUT. BASED ON OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVE SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THE SURGEON WAS MALLETING THE PS HOUSING PUNCH INSTRUMENT (PN: 9304-4102) INTO THE DEDICATED SLOT AS INTENDED BY SURGICAL TECHNIQUE. DURING THE FINAL HIT OF THE MALLET, THE PS HOUSING COMPONENT BROKE INTO MULTIPLE PIECES. IT OCCURRED AT THE END OF THE SURGERY AFTER THE BONE WAS ALREADY REMOVED, SO A BACKUP INSTRUMENT WAS NOT REQUIRED. ALL STAFF CAREFULLY REMOVED THE BROKEN PIECES FROM THE SURGICAL FIELD, CONFIRMING NONE FELL INTO THE SURGICAL SITE. AGENT ON SITE DURING THE SURGERY WAS INTERVIEWED AND CONFIRMED THAT THE INSTRUMENT WAS USED ACCORDING TO THE STANDARD PROCEDURE. THE BROKEN PS HOUSING PUNCH HAS BEEN DISCARDED BY THE HOSPITAL INADVERTENTLY RESULTING IN NO FURTHER ANALYSIS OR INSPECTION OF THE AFFECTED INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363658 PS HOUSING PUNCH PS HOUSING PUNCH HWP UNITED ORTHOPEDIC CORPORATION 9304-4102 T16L428A1 04719872175537

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female