BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE

    MDR report key: 24968164 · Received April 23, 2026

    Report

    Report Number
    8030965-2026-03741
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 7, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819055469
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 DURING SURGERY, THE L95MM COLLUM SCREW DID NOT FIT INTO THE 4 HOLE DHS PLATE. THEY HAD TO USE L90MM SCREW THAT ENTERED SUCCESSFULLY INTO THE PLATE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565161 DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM-STERILE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 62266P3 07611819055469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown