BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION

    MDR report key: 24005292 · Received January 8, 2026

    Report

    Report Number
    8030965-2026-00261
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 17, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819020252
    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 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. H11 ADDITIONAL NARRATIVE: H6: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION OF " 315.920, DRILL BIT Ø2.5 CALIBR L230/205 3FLUTE F/" REVEALED THAT THE TIP OF THE DRILL BIT HAS BEEN BROKEN. 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 Ø2.5 CALIBR L230/205 3FLUTE F/ WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO COMPONENT FAILURE 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. DEVICE HISTORY LOT: LOT # PROVIDED IS NOT A VALID NUMBER, THEREFORE, THE DHR COULD NOT BE COMPLETED. IF DEVICE IS RETURNED OR LOT NUMBER CAN BE CONFIRMED, THE DHR WILL BE REVISITED. 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 THE PROCEDURE, WHILE PERFORMING THE DRILLING, THE CALIBRATED 2.5 MM DRILL BIT, 230/205 MM IN LENGTH, BROKE. THIS ISSUE WAS IMMEDIATELY RESOLVED BY REMOVING THE BIT AND PROVIDING THE DOCTOR WITH ANOTHER DRILL BIT OF THE SAME SPECIFICATIONS, WHICH WAS ALSO INCLUDED IN THE KIT. WITH THIS NEW BIT, THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS INCIDENT CAUSED NO DISCOMFORT TO THE SPECIALIST, NO ADVERSE EFFECTS ON THE PATIENT, AND NO ALTERATIONS TO THE SURGICAL SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62030 2.5MM THREE-FLUTED DRILL BIT QC/230MM/200MM CALIBRATION DRILL BIT HTW SYNTHES GMBH P-31357 07611819020252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female