BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 4850496 · Received June 17, 2015

    Report

    Report Number
    2520274-2015-14502
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 3, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    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

    LOT NUMBER OBTAINED UPON RECEIPT OF SUBJECT DEVICE. SUBJECT DEVICE RECEIVED ON JUN 23, 2015. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. A PRODUCT DEVELOPMENT INVESTIGATION WAS ALSO PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 357.377, LOT NUMBER 4984965, HELICAL BLADE COUPLING SCREW). THE RETURNED DEVICE SHOWS SIGNIFICANT USE DURING ITS 9+ YEAR LIFESPAN. THE DEVICE HAS NUMEROUS MARKS, DENTS, AND ROLL MARKS ON THE SHAFT AND KNOB THAT ARE CONSISTENT WITH REGULAR HAMMER STRIKES AND USE. THE KNOB WAS RECEIVED DETACHED FROM THE SHAFT. THIS COMPLAINT CONDITION IS CONFIRMED, AND THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS EXCESSIVE HAMMERING DURING USE OVER TIME. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. SYNTHES MANUFACTURING LOCATION WAS IDENTIFIED UPON RECEIPT OF SUBJECT DEVICE LOT NUMBER. 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 DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE THE HELICAL BLADE COUPLING SCREW BROKE AS IT WAS BEING REMOVED. ANOTHER INSTRUMENT WAS UTILIZED TO REMOVE THE DISTAL PORTION OF THE BROKEN COUPLING SCREW. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY RELATED TO THIS EVENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 24, 2015. IT WAS REPORTED THAT THE EVENT OCCURRED DURING SURGERY ON (B)(6) 2015 AND THAT THE COMPLAINED EVENT RESULTED IN A SURGICAL DELAY OF 5 TO 10 MINUTES. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392767 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4984965

    Patients

    Seq Age Sex Outcome Treatment
    1