BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 9156054 · Received October 4, 2019

    Report

    Report Number
    2939274-2019-61185
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    June 1, 2019
    Report Date
    June 1, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCCUPATION: SYNTHES EMPLOYEE. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 (B)(6) 2019, DURING AN UNKNOWN PROCEDURE WHILE INSERTING THE FEMORAL RECON NAIL (FRN), THE FRN INSERTION HANDLE AND DRIVING CAP BROKE. THE NAIL WASN¿T INSERTED AS FAR AS SURGEON WANTED. IT WAS AN INTRAOPERATIVE EVENT. THIS WAS DUE TO THE 14 MM ENTRY REAMER NOT BEING LONG ENOUGH FOR THE NAIL TO BE INSERTED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN FEMORAL RECON NAIL (FRN) (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN REAMER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951211 DRIVING CAP/THREADED MISC. ORTHO SURGICAL INSTR LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.523 10886982069351

    Patients

    Seq Age Sex Outcome Treatment
    1