BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM

    MDR report key: 5224410 · Received November 15, 2015

    Report

    Report Number
    2520274-2015-17260
    Event Type
    Injury
    Date Received
    November 15, 2015
    Report Date
    September 15, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    PK023941
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) UNKNOWN ¿ ORIGINAL IMPLANT OCCURRED APPROXIMATELY TWELVE (12) WEEKS PRIOR TO THE REVISION PROCEDURE. (B)(6). MANUFACTURING INVESTIGATION EVALUATION: THE SCREW WAS RECEIVED WITHOUT THE SCREW HEAD, WHICH HAD BROKEN OFF. THE HEAD WITH THE PRINTED ON ARTICLE NUMBER WAS NOT RETURNED. DUE TO THE DAMAGE TO THE SCREW HEAD, IT COULD NOT BE MEASURED. ALL MEASURABLE DIMENSIONS, WITHOUT DAMAGE, WERE EVALUATED AND FULFILLED THE SPECIFICATIONS. BASED ON THIS, THE COMPLAINT IS RATED AS CONFIRMED, BUT NOT VALID FROM MANUFACTURING POINT OF VIEW. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED. WITHOUT A VALID LOT NUMBER, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) COULD NOT BE REQUESTED. THE DHR INFORMATION THAT WAS REPORTED ON A PREVIOUS MEDWATCH (UNDER MFR# 2520274-2015-16264) WAS FOR THE EIGHT (8) INTACT SCREWS THAT WERE ALSO RECEIVED. THOSE PART/LOT COMBINATIONS ARE AS FOLLOWS: PART 413.370S / LOT 9426566, PART 413.370S / LOT 9202934, PART 413.365S / LOT 9179438, PART 413.360S / LOT 9251163, PART 413.334S / LOT 9220741, PART 413.334S / LOT 9234848. 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 IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WITH SUPRACONDYLAR FEMUR FRACTURE UNDERWENT REVISION SURGERY ON (B)(6), 2015 DUE TO POSTOPERATIVE BREAKAGE OF THE LOCKING COMPRESSION PLATE (LCP). THE ORIGINAL DATE OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT COMPLAINED PAIN ON (B)(6), 2015. WHEN SURGEON HAD INSPECTED ACCORDINGLY, THE BREAKAGE OF REPORTED PLATE WAS DETECTED. DURING THE REVISION SURGERY THE SURGEON PERFORMED THE FOLLOWING: REMOVED THE REPORTED LCP AND ASSOCIATED SCREWS; REPOSITIONED THE FRACTURED AREA; TRANSPLANTED THE ILLUM AND; PLACED A NEW IMPLANT (DISTAL FEMUR TO LATERAL FEMUR AND NARROW PLATE TO MEDIAL PART. CURRENTLY THE PATIENT IS UNDER OBSERVATION AND BEING TREATED WITH TERIPARATIDE AND AN ULTRASOUND DEVICE. THE PATIENT HAS ALSO BEEN ADVISED TO PREVENT ANY LOADING ON THE FRACTURED AREA FOR A PERIOD OF TIME (DURATION OF TREATMENT AND ABSENCE OF WEIGHT BEARING ACTIVITY UNKNOWN). UPDATE: IT WAS REPORTED THAT TWO (2) SCREWS BROKE AT THE SCREW HEADS. THE OTHER EIGHT (8) SCREWS THAT WERE REMOVED DURING THE REVISION WERE INTACT WITH NO ALLEGATIONS OF MALFUNCTION. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754143 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention