BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID INSERTION HANDLE

    MDR report key: 9311768 · Received November 12, 2019

    Report

    Report Number
    2939274-2019-62083
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 22, 2019
    Report Date
    October 23, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982070272
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY LOT PART: 03.037.011. LOT: 9910367. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: JUNE 16, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    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. (B)(4). 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 OPEN REDUCTION INTERNAL FIXATION (ORIF) OF FEMUR DUE TO HIP FRACTURE, THE FLEXIBLE SCREWDRIVER BROKE WHILE TRYING TO REMOVE FROM LOCKING THE HELICAL BLADE SET SCREW. THE 5.0 FLEXIBLE SCREWDRIVER WAS STUCK BETWEEN THE PATIENT TISSUE AND THE INSERTION HANDLE AND REQUIRED ABOVE AVERAGE PULLING FORCE IN ORDER TO REMOVE. AFTER LOCKING THE TFNA SET SCREW THE SURGEON EXPERIENCED DIFFICULTY REMOVING THE 5.0 FLEXIBLE SCREWDRIVER AND USED SUBSTANTIAL FORCE WHILE TWISTING THE DRIVER, AT WHICH POINT IT BROKE. THE LEG WAS ADDUCTED TO RELIEVE THE TENSION AND PLIERS WERE USED TO REMOVE THE REMAINING PORTION OF THE DRIVER. THERE WAS A SURGICAL DELAY OF THREE (3) MINUTES WHILE PLIERS WERE USED TO PULL OUT THE BROKEN PIECE. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN TFNA HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105707 HYBRID INSERTION HANDLE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.011 9910367 10886982070272

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE