BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASY EXPLANT BIT 9 - 45 MM SS W/SZR PIN

    MDR report key: 4951693 · Received July 28, 2015

    Report

    Report Number
    9613350-2015-00860
    Event Type
    Other
    Date Received
    July 28, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TREND ANALYSIS: A TREND WAS IDENTIFIED. A TREND INVESTIGATION HAS BEEN INITIATED. REVIEW OF INCOMING INFORMATION: LASER MARKING IS NOT READABLE ON EVERY DEVICE. NO PICTURES WERE AVAILABLE. DEVICES ANALYSIS: ALL DEVICES HAVE A LASER MARKING ON THE SHAFT. ITEM AND LOT NUMBER IS MARKED ON THE SHAFT. ON THE TOP/HEAD OF THE BIT, THE SIZE AND THE SYSTEM OF THE BIT IS MARKED. THE SURFACE OF THE DEVICE ON THE TOP/HEAD IS ROUGH. THEREFORE, THE LASER MARKING WAS NOT IDEALLY PLACED ON THE TOP/HEAD. POSSIBLE CAUSES FOR THE REPORTED EVENT ACCORDING TO DFMEA: LASER MARKING NOT LEGIBLE ON THE TOP/HEAD OF THE DEVICE DUE TO INADEQUATE DESIGN FOR INTENDED HANDLING PERFORMANCE. POSSIBLE AS THE PERFORMED INVESTIGATION SHOWED THAT THE SURFACE OF THE DEVICE ON THE TOP/HEAD WAS ROUGH. THEREFORE, THE LASER MARKING WAS NOT IDEALLY PLACED ON THE TOP/HEAD. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. THE SURFACE OF THE DEVICE ON THE TOP/HEAD IS ROUGH. THEREFORE, THE LASER MARKING WAS NOT IDEALLY PLACED ON THE TOP/HEAD. A CAPA WAS INITIATED TO ELIMINATE THE ROOT CAUSE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES FOR REVIEW. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT AT HOSPITAL, UPON RECEIPT OF ORIGINAL PACKED INSTRUMENT, IT WAS DETECTED THAT THE LASER MARKING OF THE DEVICE IS ILLEGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488781 EASY EXPLANT BIT 9 - 45 MM SS W/SZR PIN EASY EXPLANT BIT HRS NORMED MEDIZIN-TECHNIK GMBH 11830

    Patients

    Seq Age Sex Outcome Treatment
    1 Other