BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAFIX ADV PEEK SCW 8X23MM

    MDR report key: 23715449 · Received December 4, 2025

    Report

    Report Number
    1221934-2025-04593
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 4, 2025
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    MBI
    UDI-DI
    10886705027422
    PMA / PMN Number
    K160804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. H10 ADDITIONAL NARRATIVE: THE COMPLAINT DEVICE WAS DISCARDED BY THE CUSTOMER, THEREFORE NOT RETURNED TO DEPUY SYNTHES AND UNAVAILABLE FOR A PHYSICAL EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND THERE WAS A NON-CONFORMANCE UNRELATED TO THE REPORTED COMPLAINT. BASED ON THE CURRENT AVAILABLE INFORMATION, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE INTRAFIX ADV PEEK SCW 8X23MM DEVICE WHEN PLACING THE SCREW, THE DOCTOR INDICATES THAT THE SCREW DRIVER WITH THE SCREW DID NOT SCREW OR HOOKED, SO PROCEEDED TO TRY TO REMOVE IT. AT THAT MOMENT THE TIP OF THE SCREW BROKE. IT WAS POSSIBLE TO REMOVE COMPLETELY WITHOUT INCIDENTS FOR THE PATIENT. THE BROKEN SCREW WAS UNFORTUNATELY PLACED IN THE INPUT TRAY USED, SO IT WAS DISCARDED ALONG WITH THE REST. THE TECHNICAL ASSISTANT DELIVERED A NEW SCREW TO CONTINUE THE SURGERY, WHICH HAD NO MORE INCIDENTS. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801682 INTRAFIX ADV PEEK SCW 8X23MM FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI MEDOS INTERNATIONAL SàRL 265L286 10886705027422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown