BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 22709650 · Received August 4, 2025

    Report

    Report Number
    8030965-2025-07990
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 4, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: ADDED: D9, H4. H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE NEEDLE OF THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS FOUND BROKEN FROM THE SLIDER, THE NEEDLE FRAGMENT AND THE SLEEVE WERE NOT RECEIVED FOR EVALUATION, NO OTHER ISSUES WERE IDENTIFIED. A DIMENSIONAL INSPECTION FOR THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE BROKEN DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. MISSING COMPONENT CONDITION MAY OCCUR DURING THE CLEANING/STERILIZATION PROCESS, PARTICULARLY WHEN THE COMPONENTS ARE ASSEMBLED OR DISASSEMBLED. AS THESE PROCEDURES ARE OFTEN REPEATED, THERE IS AN INCREASED RISK OF COMPONENTS GOING MISSING. HOWEVER, WITHOUT CONCRETE EVIDENCE OR FURTHER INFORMATION, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION.ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART # 319.006, SYNTHES LOT # H873105, SUPPLIER LOT # H873105, RELEASE TO WAREHOUSE DATE: 15 SEPT 2020, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, REP NOTICED THAT THERE WERE SOME THAT WERE DAMAGED. REP DOES NOT KNOW WHEN THIS DAMAGE OCCURRED WHETHER IT WAS POSTOP OR PREOP. THERE WAS NO PATIENT INVOLVEMENT. SOME OF THE INSTRUMENTS HAVE TO BE ABLE TO SEND BACK, BUT THERE ARE A COUPLE THAT WILL NOT BE ABLE TO RETURN BECAUSE THEY WERE DISPOSED OF BY THE FACILITY. REP KNOWS THE LOT NUMBER ON SOME OF THEM, BUT THE ONES THAT WERE DISPOSED OF REP DOES NOT KNOW THE LOT NUMBER. 1. PRODUCT # 314.118, LOT # H887026, QUANTITY (B)(4). THIS ITEM IS A T25 SCREWDRIVER, AND THE TIP OF THE SCREWDRIVER IS STRIPPED. THIS ITEM IS AVAILABLE FOR RETURN. 2. PRODUCT # 03.127.010, LOT # 8391544, QUANTITY (B)(4). THIS ITEM IS A DRILL SLEEVE FOR AN AIMING ARM, AND THE TIP OF IT IS BENT AND NEEDS REPLACED. THIS ITEM IS AVAILABLE FOR RETURN. 3. PRODUCT # 319.006, LOT # H873105, QUANTITY (B)(4). THIS ITEM IS A DEPTH GAUGE, AND THE TIP OF THE DEPTH GAUGE IS BROKE OFF. THIS ITEM IS AVAILABLE FOR RETURN. 4. PRODUCT. # 03.333.301, LOT # UNKNOWN, QUANTITY (B)(4). THESE TWO ITEMS ARE POWER SHAFTS T6 AND THE TIPS OF THEM WERE STRIPPED. THESE ITEMS ARE NOT AVAILABLE FOR RETURN DUE TO THE FACILITY DISPOSING OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429675 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS DEPTH GAUGE HTJ SYNTHES GMBH H873105 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown