BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS. CHANDLER RETRACTOR

    MDR report key: 6014989 · Received October 10, 2016

    Report

    Report Number
    0002249697-2016-03202
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 14, 2016
    Report Date
    March 8, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. PRODUCT DISCARDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURED SCREWS INVOLVING A MIS. CHANDLER RETRACTOR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION NOT COMPLETED AS DEVICE WAS NOT RETURNED MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE NOT RECEIVED FOR EVALUATION. DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EVENT WAS NOT CONFIRMED NOR COULD THE ROOT CAUSE BE DETERMINED BECAUSE THE INSTRUMENT WAS NOT RETURNED FOR EVALUATION AND INSUFFICIENT INFORMATION WAS PROVIDED. A SUPPLIER REVIEW OF THE EVENT CONCLUDED "NO ACTION IS REQUIRED AT THIS TIME AS THE DEVICE WAS NOT RETURNED, THERE IS NO CONFIRMATION OF A MANUFACTURING ISSUE" AS PER ATTACHED FULL INVESTIGATION REPORT. IF THE INSTRUMENT AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WELD ON THE CHANDLER RETRACTOR WHICH HOLDS THE SCREW ON HAS SNAPPED OFF. NO PARTS FELL INTO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WELD ON THE CHANDLER RETRACTOR WHICH HOLDS THE SCREW ON HAS SNAPPED OFF. NO PARTS FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667160 MIS. CHANDLER RETRACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G3730457

    Patients

    Seq Age Sex Outcome Treatment
    1 Other