BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS AL CASE FULL MID HEIGHT

    MDR report key: 22938766 · Received September 2, 2025

    Report

    Report Number
    1818910-2025-15034
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 13, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    FSM
    UDI-DI
    10603295503521
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY- THE DEVICE WAS REPORTED FOR AN UNKNOWN REASON. IT DIDN'T HAPPEN IN SURGERY. A PIPE CLEANER MELTED ONTO THE INSIDE OF THE TRAY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT TWO PIPES CLEANERS AND PLASTIC ARE MELTED ON ONE OF THE DPS AL CASE FULL MID HEIGHT INNER SIDES. NO OTHER ANOMALIES WERE NOTED. POTENTIAL CAUSE FOR THE FOREIGN SUBSTANCE CAN BE TRACED TO MAINTENANCE, AS THIS KIND OF CONDITION MAY HAPPEN DUE TO IMPROPER CLEANING/STERILIZATION. AS PER IFU-0902-60-025 INSTRUMENTS MUST BE CLEANED SEPARATELY FROM INSTRUMENT TRAYS AND CASES IN MANUAL CLEANING STEPS. INSTRUMENTS AND THE TRAYS/CASES SHOULD BE THOROUGHLY CLEANED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE DPS AL CASE FULL MID HEIGHT WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO MAINTENANCE 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 REPORTED 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. DEVICE HISTORY LOT- THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIPE CLEANER MELTED ONTO THE INSIDE OF THE TRAY. THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997024 DPS AL CASE FULL MID HEIGHT TRAY, SURGICAL, INSTRUMENT FSM DEPUY IRELAND - 3015516266 RU0432027 10603295503521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown