BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE X25 INSERTER/TIGHTENER

    MDR report key: 10159575 · Received June 16, 2020

    Report

    Report Number
    1526439-2020-01194
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 4, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWR
    UDI-DI
    10705034467634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL NARRATIVE: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED: INVESTIGATION FLOW: DAMAGE VISUAL INSPECTION: THE VERSE X25 INSERTER/TIGHTENER (P/N: 299704230, LOT NUMBER: GM5355603) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE HEXALOP TIP OF THE DEVICE WORN OUT AND WAS ALMOST ROUNDED. NO OTHER VISUAL NON-CONFORMITY WAS IDENTIFIED DEVICE FAILURE/DEFECT IDENTIFIED? YES DIMENSIONAL INSPECTION: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE HEXALOP TIP OF THE VERSE X25 INSERTER/TIGHTENER (P/N: 299704230, LOT NUMBER: GM5355603) WAS WORN OUT AND WAS ALMOST ROUNDED. NO DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION BUT IT IS LIKELY THAT THE WEAR OUT WAS A SIGN OF END OF LIFE OF THE DEVICE. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT A REVIEW OF THE RECEIVING INSPECTION (RI) FOR VERSE X25 INSERTER WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GM5355603 WAS RELEASED IN A SINGLE BATCH. ¿ BATCH1: LOT QTY OF 91 UNITS WERE RELEASED ON DEC 20, 2018 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE HISTORY REVIEW THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS COMPANY REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING THE SURGERY THE INSERTER TIP WAS DAMAGED. IT WAS UNKNOWN IF THE SURGERY DELAYED AND COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623105 VERSE X25 INSERTER/TIGHTENER DRIVER HWR MEDOS INTERNATIONAL SàRL CH 299704230 GM5355603 10705034467634

    Patients

    Seq Age Sex Outcome Treatment
    1