BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM

    MDR report key: 20138498 · Received September 4, 2024

    Report

    Report Number
    8030965-2024-10722
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819240551
    PMA / PMN Number
    K000682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H6: THE SUBJECT DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 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. H3 H4 H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND TO BE STRIPPED FROM THE THREADS. THE DEVICE EXHIBITS NORMAL WEAR DAMAGE AT THE EXTERNAL THREADS CONSISTENT WITH IMPLANTATION AND EXPLANTATION PROCEDURE. A DIMENSIONAL INSPECTION FOR THELOCKSCR Ø5 SELF-TAP L38 TAN WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. A FUNCTIONAL EVALUATION WAS UNABLE TO PERFORMED DUE TO MATING DEVICE WERE NOT RECEIVED TO ASSESS THE INTERACTION OF THE DEVICES. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE LOCKSCR Ø5 SELF-TAP L38 TAN WOULD CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR) A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE. PRODUCT CODE: 413.338S-15, LOT NUMBER: 7288P09, THE PRODUCT WAS RELEASED ON: 04-SEP-2023, MANUFACTURING SITE:JABIL GRENCHEN, EXPIRY DATE:01-AUG-2033. 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 · 0

    IT WAS REPORTED THAT THERE WAS A POST PERI-IMPLANT DISTAL FEMUR FRACTURE IN JANUARY 2024 WITH LEFT KNEE TEP IN PLACE. IN CASE OF SCREW LOOSENING, A REVISION PROCEDURE WAS PERFORMED IN (B)(6) 2024 USING LCP DISTAL FEMUR PLATE WITH LISS. ON (B)(6) 2024 THE PATIENT PRESENTED TO OUR TRAUMA SURGERY OUTPATIENT CLINIC AS AN UNSCHEDULED CASE AFTER, THE PATIENT NOTICED A CRACKING NOISE WHEN CLIMBING THE STAIRS WITH UAGST. THE SUBSEQUENT DIAGNOSTICS REVEALED A CENTRAL FRACTURE OF THE PLATE AND A SLIGHT AXIAL DEVIATION WITH RECURRENCE, AXIAL DEVIATION WITH RECURVATION. ADDITIONAL PRODUCTS WERE RETURNED TO THE MANUFACTURER AND NOTICED TO BE STRIPPED. THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM. THIS IS REPORT 10 OF 10 FOR (B)(4). THE BROKEN PLATE IS CAPTURED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833624 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 7288P09 07611819240551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male