BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM CALIBRATED DRILL BIT QC 250MM/95MM

    MDR report key: 16708713 · Received April 10, 2023

    Report

    Report Number
    8030965-2023-04372
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    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

    DEPUY SYNTHOS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. REPORTER IS A J&J EMPLOYEE. PART:03.113.023 LOT:L203045 MANUFACTURING SITE: WERK BETTLACH SUPPLIER: NA RELEASE TO WAREHOUSE DATE:(B)(6) 2016 EXPIRATION DATE: NA A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCE'S WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHESE FOR EVALUATION. THE DEPUY SYNTHESE TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DRILL BIT Ø2.5 W/STOP CALIBER L250/225 F/ WAS BROKEN FROM THE DISTAL TIP, FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. ADDITIONALLY, THE STOP RING WAS MISSING FROM THE DEVICE. A DIMENSIONAL INSPECTION FOR THE DRILL BIT Ø2.5 W/STOP CALIBER L250/225 F/ WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. AS PART OF DEPUY SYNTHESE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE DRILL BIT Ø2.5 W/STOP CALIBER L250/225 F/. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON (B)(6) 2022. THERE WAS NO ALLEGATION REPORTED AGAINST THE DEVICE. UPON PRODUCT RETURN AND INVESTIGATION ON (B)(6) 2023, IT WAS FOUND THAT THE ITEM WAS BROKEN FROM THE DISTAL TIP. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912180 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM BIT, DRILL HTW SYNTHES GMBH L203045 07611819351813

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown