BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR LARGE SCREWS

    MDR report key: 16163036 · Received January 13, 2023

    Report

    Report Number
    8030965-2023-00542
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Date of Event
    October 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ONLY THE EVENT MONTH AND YEAR ARE KNOWN. INITIAL REPORTER ADDRESS: (B)(6). INITIAL REPORTER PHONE NUMBER REPORTED AS (B)(6). THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DEPTH GAUGE F/SCR Ø4.5 - 6.5 MEAS-RANGE WAS BENT FROM THE TIP. THE OBSERVED CONDITION WAS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. A FUNCTIONAL TEST WAS PERFORMED TO DEVICE AND THE SLIDER CAN BE MOVED FORWARD AND BACKWARD SMOOTHLY. THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED. AFTER A VISUAL INSPECTION, IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE WAS BENT FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED TIP BENT OF DEPTH GAUGE F/SCR Ø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

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2022, THE CUSTOMER REPORTS THAT THE INSTRUMENTS ¿HOOK¿ AGAIN AND AGAIN, DO NOT RUN SMOOTHLY, AND THUS COMPLICATE THE SURGERIES OR EXTEND THE SURGERY TIME. THE INSTRUMENT CANNOT BE DISASSEMBLED; THE INSTRUMENT DOES NOT FIX; THE INNER PART FALLS OUT. THERE WAS NO PATIENT HARM, AND NO INTERVENTION OCCURRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DEPTH GAUGE FOR LARGE SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963886 DEPTH GAUGE FOR LARGE SCREWS GAUGE, DEPTH HTJ SYNTHES GMBH L118179

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DEPTH GAUGE F/SCR Ø4.5 - 6.5 MEAS-RANGE| MEASURING DEVICE F/LOCKBOLT