BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM CALIBRATED DRILL BIT QC 250MM/95MM

    MDR report key: 24800215 · Received April 7, 2026

    Report

    Report Number
    8030965-2026-03188
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 18, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    UDI-DI
    07611819351813
    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H3, H6: THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE RECEIVED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT '03.113.023, DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/ 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. THE PHOTOGRAPHS WERE REVIEWED, HOWEVER, THE EVIDENCE PROVIDED WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF EMBEDDED DEVICE. FUNCTIONALITY AND DEVICE INTERACTION ISSUES CANNOT BE EVALUATED THROUGH PHOTO INVESTIGATION. 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 W/STOP CALIBR L250/225 F/ WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE ¿DRILL BIT Ø2.5 W/STOP CALIBR L250/225 F/¿ HAS BROKEN PIECES AT THE TIP. 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

    DURING THE PROCEDURE, WHILE THE DOCTOR WAS PERFORMING THE DRILLING USING A CALIBRATED, STOPPED 2.5 MM DIAMETER DRILL BIT (LENGTH 250/225 MM, QUICK-COUPLING), THE BIT FRACTURED, LEAVING A SMALL FRAGMENT EMBEDDED WITHIN THE PATIENT'S BONE. THE DOCTOR ATTEMPTED TO RETRIEVE THE FRAGMENT BUT WAS UNABLE TO DO SO; CONSEQUENTLY, HE DECIDED TO LEAVE THE TIP IN PLACE, CITING THE DIFFICULTY OF EXTRACTION AND THE FACT THAT LEAVING IT WITHIN THE BONE WOULD POSE NO ISSUES. THE SITUATION WAS RESOLVED BY REMOVING THE REMAINDER OF THE FRACTURED DRILL BIT AND INSERTING A REPLACEMENT BIT WITH IDENTICAL SPECIFICATIONS, WHICH WAS ALSO INCLUDED IN THE SURGICAL KIT. THE INCIDENT CAUSED NO DISRUPTION TO THE SPECIALIST. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DEVIATION FROM THE SCHEDULED SURGICAL TIMELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857596 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM BIT, DRILL HTW SYNTHES GMBH 07611819351813

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown