BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER

    MDR report key: 9695597 · Received February 11, 2020

    Report

    Report Number
    3013730328-2020-00010
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    May 1, 2019
    Report Date
    February 4, 2020
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    LXH
    UDI-DI
    04260397080849
    PMA / PMN Number
    K170503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUBMISSION NUMBER K172888. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HAMMER WAS CONDUCTED IDENTIFYING THAT THE LOT NUMBER E15DI0029 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON JUNE 2015. AS A RESULT, THE DHR IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. VISUAL INSPECTION: THE HAMMER (P/N: PET60250, LOT #: E15DI0029) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE POLY CAP WAS BROKEN AT THE MOST PROXIMAL THREAD OF THE DEVICE AND THE BROKEN FRAGMENT WAS RETURNED LODGED INSIDE THE HAMMERHEAD. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON THE FUNCTIONALITY OF THE DEVICE. NO OTHER ISSUES WERE OBSERVED WITH THE RETURNED COMPONENTS OF THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS BROKEN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE HAMMER (P/N: PET60250, LOT #: E15DI0029). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE WHITE PLASTIC PART OF THE HAMMER IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157401 HAMMER MISC ORTHO SURGICAL INSTR LXH EIT EMERGING IMPLANT TECHNOLOGIES GMBH PET60250 E15DI0029 04260397080849

    Patients

    Seq Age Sex Outcome Treatment
    1