BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MM DRILL BIT/JC/130MM

    MDR report key: 24755975 · Received April 1, 2026

    Report

    Report Number
    8030965-2026-03018
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 14, 2026
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    UDI-DI
    07611819018709
    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: E1 INITIAL REPORTER ADDRESS LINE 1: CENTRO CL DEL CURATO 38 102 BRR CENTRO HISTORICO H3, H6: PART: 310.320 LOT: 8849278 MANUFACTURING SITE: WERK BETTLACH SUPPLIER: NA RELEASE TO WAREHOUSE DATE: 20 FEB 2014 EXPIRATION DATE; NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PHOTO INVESTIGATION REVEALED THAT DRILL BIT Ø3.2 L130/115 2FLUTE HAD BROKEN. THE OBSERVED CONDITION OF THE DEVICE WAS CONSIST WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCE. THE INVESTIGATION WAS NOT ABLE TO CONFIRM THE ALLEGATION OF EMBEDDED DEVICE AS NO X-RAYS WERE PROVIDED TO EVALUATE THE CONDITION. 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 Ø3.2 L130/115 2FLUTE WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRILL BIT Ø3.2 L130/115 2FLUTE BROKE DURING AN INTRAOPERATIVE PROCEDURE. THE TIP OF THE DRILL BIT BECAME EMBEDDED IN THE PATIENT'S BONE, BUT IT WAS STATED THAT THIS DID NOT AFFECT THE PATIENT SINCE IT REMAINED WITHIN THE BONE. THE SURGERY WAS PROLONGED DUE TO THE NEED FOR ADDITIONAL INSTRUMENTS, RESULTING IN A BRIEF DELAY, BUT WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817247 3.2MM DRILL BIT/JC/130MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE SYNTHES GMBH 8849278 07611819018709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male