BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    16MM CANNULATED HOLLOW DRILL BIT

    MDR report key: 10970398 · Received December 8, 2020

    Report

    Report Number
    2939274-2020-05502
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Report Date
    October 15, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982070203
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PART 03.037.004, LOT 190483-201: MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: MARCH 03, 2020. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, THE LASER WELD TO SECURE THE SPRING COMPONENT TO THE CENTERING ATTACHMENT WAS BROKEN. THE SPRING COMPONENT WAS NOT RETURNED. NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE AND THE SPRING NOT RETURNED. THE RELEVANT DRAWINGS WERE REVIEWED; NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. THE COMPLAINT CONDITION WAS CONFIRMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    IT WAS REPORTED ON AN UNKNOWN DATE, DURING STERILE PROCESSING THE CANNULATED HOLLOW DRILL BIT WAS MISSING THE RETENTION PIN. AS A RESULT, THE SLIDING PIECE WILL NOT STAY IN POSITION. THERE WAS NO PATIENT INVOLVEMENT. DURING THE INVESTIGATION BY THE MANUFACTURER, IT WAS NOTED THAT THE LASER WELD TO SECURE THE SPRING COMPONENT TO THE CENTERING ATTACHMENT WAS BROKEN. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429531 16MM CANNULATED HOLLOW DRILL BIT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.004 190483-201 10886982070203

    Patients

    Seq Age Sex Outcome Treatment
    1