BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 9145250 · Received October 2, 2019

    Report

    Report Number
    2939274-2019-61110
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Report Date
    September 6, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982069351
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. VISUAL INSPECTION: THE DRIVING CAP/THREADED (P/N 03.010.523 LOT L800837) WAS RECEIVED SHOWING THE THREADED DISTAL TIP BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. THE BROKEN OFF TIP WAS RETURNED EMBEDDED IN THE RETURNED CONCOMITANT INSERTION HANDLE (PART #: 03.033.001, LOT #: L785923). THE DRIVING CAP IN A USED CONDITION AS THERE ARE NUMEROUS HAMMER/IMPACTION MARKS ON THE CAP. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. THE INSERTION HANDLE (PART #: 03.033.001, LOT #: L785923) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. DIMENSIONAL INSPECTION: FEATURE: DIAMETER OF SHAFT ADJACENT TO DISTAL THREADED TIP, SPECIFICATION: 7.8 MM +/- 0.1 MM, MEASURED DIMENSION: 7.77 MM, RESULT: CONFORMING. DIMENSIONAL INSPECTION OF THE THREADS COULD NOT BE CONDUCTED AS THE REMAINING THREAD FORM ON THE DRIVING CAP DOES NOT PROVIDE AN ACCURATE MEASUREMENT FOR ANY THREAD DIAMETERS. THE THREADED TIP FRAGMENT IS EMBEDDED IN THE HANDLE AND COULD NOT BE INSPECTED. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE DRIVING CAP/THREADED (P/N 03.010.523 LOT L800837) AS THE THREADED DISTAL TIP WAS BROKEN OFF AT THE MOST PROXIMAL THREAD FORM. THE BROKEN OFF TIP WAS RETURNED EMBEDDED IN THE RETURNED CONCOMITANT INSERTION HANDLE (PART #: 03.033.001, LOT #: L785923). WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED EXCESSIVE FORCES AND/OR OFF-AXIS STRIKING. BASED ON THE INVESTIGATION FINDINGS RELEVANT ACTIONS HAVE BEEN TAKEN. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DURING THE INVESTIGATION NO NEW POTENTIAL PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 THAT ON AN UNKNOWN DATE, THAT THE TIP OF THE DRIVING CAP BROKE OFF INSIDE OF A RADIOLUCENT INSERTION HANDLE FOR FEMORAL RECON NAIL. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE/S REPORTED: RADIOLUCENT INSERTION HANDLE (PART 03.033.001, LOT L785923, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRIVING CAP/THREADED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939804 DRIVING CAP/THREADED MISC. ORTHO SURGICAL INSTR. LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 L800837 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1