BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1 L46/34 2FLUTE

    MDR report key: 24829150 · Received April 9, 2026

    Report

    Report Number
    8030965-2026-03295
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 17, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819080997
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. H3, H6: PRODUCT CODE: 513.005 LOT NUMBER : 347688 RELEASE TO WAREHOUSE DATE : 13. JUN. 2023 SUPPLIER: HIPP MEDICAL AG. MANUFACTURING SITE: WERK SELZACH A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT ' DRILL BIT Ø1 L46/34 2FLUTE 347688" HAS BROKEN PIECES AT THE TIP. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DRILL BIT Ø1 L46/34 2FLUTE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE ¿DRILL BIT¿ HAS ¿BROKEN¿ BECAUSE OF UNINTENDED FORCE, 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 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 THE DRILL BIT Ø1 L46/34 2FLUTE BROKE INTO MULTIPLE PIECES DURING A SURGICAL PROCEDURE. THE FRAGMENTS WERE PROMPTLY REMOVED AND REPLACED WITH ANOTHER DRILL BIT OF THE SAME SPECIFICATIONS FROM THE KIT, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EFFECTS OR CHANGES TO THE SURGICAL SCHEDULE. THE BROKEN DRILL BIT WAS REPLACED WITH A NEW ONE UPON RETURN TO THE MANUFACTURER, AND PHOTOGRAPHIC EVIDENCE WAS PROVIDED FOR REVIEW. THERE WAS NO PATIENT CONSEQUENCE OR INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890776 DRILL BIT Ø1 L46/34 2FLUTE DRILL BIT HTW SYNTHES GMBH 347688 07611819080997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male