BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM

    MDR report key: 12639499 · Received October 15, 2021

    Report

    Report Number
    8030965-2021-08729
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Report Date
    August 3, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819908529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PART: 04.503.224.04C, LOT: 54P1839, MANUFACTURING SITE: (B)(4), SUPPLIER: SYNTHES USA HQ, INC. RELEASE TO WAREHOUSE DATE: MAY 07, 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SCR Ø1.5 SELF-DRILL L4 TAN 4U I/CLIP WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THIS COMPLAINT OF AN EMPTY SEALED POUCH HAS BEEN CONFIRMED AND IS A VALID COMPLAINT. AFTER REVIEW OF THE WORKORDER, THERE WAS AN ERROR MADE AT FLOW EXPORT PACK/LABEL WHERE THE OPERATOR MISSED AN EMPTY POUCH. DOCUMENT/SPECIFICATION REVIEW: AS PER THE DEVICE HISTORY RECORD (DHR) REVIEW FOR PART 04.503.224.04C LOT 54P1839, NO ISSUES WERE RECORDED. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT'S NOT PERTAINING TO COMPLAINT CONDITION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR EMPTY PACKAGE. THE ROOT CAUSE OF THE COMPLAINT CONDITION CAN BE ASSIGNED DUE TO THE MANUFACTURING ERROR. THE DETAILED MANUFACTURING INVESTIGATION WAS COMPLETED. THE OPERATOR MISSED THE OPERATION FLOW EXPORT PACK/LABEL THAT RESULTED IN THE COMPLAINT CONDITION. 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 THE PACKAGING WAS SEALED AND EMPTY WHEN THE CUSTOMER RECEIVED IT. THIS REPORT IS FOR A TITANIUM (TI) MATRIXMIDFACE SCREW SELF-DRILLING 4MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541111 TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM SCREW, FIXATION, BONE HWC SYNTHES GMBH 54P1839 07611819908529

    Patients

    Seq Age Sex Outcome Treatment
    1