BEUDAMED
    FDA Adverse Event Other Summary report: N

    TWIST D 20X103MM AO 2.7MM SCR BLU

    MDR report key: 4751497 · Received May 1, 2015

    Report

    Report Number
    9613350-2015-00503
    Event Type
    Other
    Date Received
    May 1, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 7, 2015
    Manufacturer
    NORMED MEDIZIN-TECHNIK GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS WERE MADE AVAILABLE. THE DHR REVIEW SHOWS THAT THE PROCESS STEP COLOR CODING WAS NOT PERFORMED. A TREND WAS IDENTIFIED (52 PIECES AFFECTED IN THIS COMPLAINT) . A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED AT NORMED. THE CAPA NUMBER IS (B)(4). THE VISUAL EXAMINATION OF THE DELIVERED DEVICES SHOWS THAT THE AFFECTED DEVICES DO NOT HAVE A COLOR CODING AS IT SHOULD HAVE LIKE IN THE TECHNICAL DRAWING. NO OTHER ABNORMALITIES CAN BE FOUND. THE FUNCTION OF THE DEVICE IS NOT AFFECTED BY MISSING COLOUR CODING. ADDITIONALLY, THE SIZE OF THE DEVICE IS LASER MARKED CORRECTLY. A HEALTH HAZARD EVALUATION WAS PERFORMED AND SHOWED THAT NO IMMEDIATE OR LONG RANGE HEALTH CONSEQUENCES (INJURIES OR ILLNESS) ARE EXPECTED. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THIS ISSUE. THE PROCESS STEP "COLOR CODING" WAS NOT DONE DURING MANUFACTURING. ACCORDING TO THE TECHNICAL DRAWING, THE COLOR CODING SHOULD BE ON THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR OTHER SOURCE DOCUMENTS 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 WAS REPORTED THAT, WHILE CHECKING THE MANUFACTURING PAPERS OF THE TWIST D 20X103MM AO 23MM 2.7MM SCR BLU, IT WAS FOUND THAT THE COLOURED MARKING ON THE DRILL WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289341 TWIST D 20X103MM AO 2.7MM SCR BLU TWIST DRILL HTW NORMED MEDIZIN-TECHNIK GMBH NA 16830

    Patients

    Seq Age Sex Outcome Treatment
    1