BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5614917 · Received April 28, 2016

    Report

    Report Number
    2520274-2016-12330
    Event Type
    Injury
    Date Received
    April 28, 2016
    Report Date
    April 25, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEVICE BREAKAGE IS UNKNOWN. THE ISSUE WAS DISCOVERED DURING THE REVISION PROCEDURE, WHICH WAS INTENDED TO ADDRESS THE PATIENT¿S NON-UNION. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW WITH PARTIAL PART NUMBER 459.XX. THE FOLLOWING INFORMATION HAS BEEN CONFIRMED FOR THE PART FAMILY PROVIDED BY THE REPORTER. 4.9MM TI LOCKING BOLT (VARIETY OF LENGTHS/SIZES) ¿ HTY: PIN, FIXATION, SMOOTH THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2015. PER FACILITY, THE COMPLAINANT PART IS NOT AVAILABLE FOR RETURN. THEREFORE, AN EVALUATION IS NOT ANTICIPATED. (B)(6). 510K: UNKNOWN, AS THE SPECIFIC PART NUMBER FOR THE DEVICE WAS NOT REPORTED. BASED UPON THE PROVIDED PART FAMILY, THE LIKELY 510K NUMBER IS K970733. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2016 DUE TO NON-UNION. THE PATIENT WAS ORIGINALLY TREATED IN (B)(6) 2015 WITH THE IMPLANTATION OF A HELICAL BLADE AND FEMORAL NAIL. ADDITIONALLY, AN UNKNOWN SCREW WAS PLACED AT THE DISTAL END OF THE NAIL DURING THAT ORIGINAL PROCEDURE. MORE THAN ONE (1) YEAR LATER, A NON-UNION WAS CONFIRMED. AS A RESULT, THE PATIENT RETURNED TO THE OPERATING ROOM FOR A FEMORAL RE-NAILING PROCEDURE. THE 11MM TITANIUM NAIL WAS REMOVED AND REPLACED WITH A 12MM TITANIUM NAIL. THE BLADE AND ONE SCREW (WITH PARTIAL PART NUMBER 459.XX) WERE ALSO REMOVED. IT WAS THEN THAT THE SURGEON NOTICED THE SCREW HAD BROKEN WITHIN THE PROXIMAL STATIC HOLE OF THE NAIL. THE SURGEON CONFIRMED THAT THE BREAKAGE HAD NOT OCCURRED INTRA-OPERATIVELY. NONETHELESS, THE BROKEN PIECE OF THE SCREW COULD NOT BE RETRIEVED AND WAS ULTIMATELY LEFT IN SITU. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT REPORTS OF DELAY. THE PATIENT'S OUTCOME WAS NOTED TO BE "STABLE." CONCOMITANT DEVICES REPORTED: HELICAL BLADE (PART/LOT NUMBERS UNKNOWN, QUANTITY: 1); FEMORAL NAIL (PART 474.138S, LOT NUMBER UNKNOWN, QUANTITY: 1) . THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270787 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN - HELICAL BLADE