BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN DISTRACTOR

    MDR report key: 21534921 · Received March 6, 2025

    Report

    Report Number
    3020584246-2025-00026
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 12, 2025
    Manufacturer
    SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC
    Product Code
    HWB
    UDI-DI
    00810112596250
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    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: A3A, D9, E1, H4. H3, H6: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION AND SEND TO THE SUPPLIER FOR FURTHER INVESTIGATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THERE IS A BROKEN PIN OR OLIVE WIRE JAMMED IN ONE OF THE FOUR HOLES THAT HAS BEEN SHEARED OFF SITTING FLUSH AND FILLING THE HOLE ON THE SMALLER .071 +.008 /-.002 INCH HOLE. A DIMENSIONAL INSPECTION WAS PERFORMED AND THERE ARE TWO SETS OF TWO HOLES ON THE PROXIMAL OR BUSINESS END OF THE DEVICE. ONE SET OF HOLES IS DIAMETER AT 2X .071 +.008/-.002 INCHES. THE OTHER HAS DIAMETER 2X .106 +.008/-.002 INCHES. DIMENSION INVESTIGATION WILL VERIFY THAT THRU HOLES ARE TO SPECIFICATION. THE DEVICE CANNOT FUNCTION AS INTENDED AS ONE HOLE IS OBSCURED BY FOREIGN OBJECT IN HOLE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE PIN DISTRACTOR WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, 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 HENCE A ROOT CAUSE CANNOT BE ESTABLISHED. AS PART OF J&J MEDTECH ORTHOPAEDICS 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 REVIEW: PRODUCT CODE: 03.900.394. LOT NUMBER: 107198R. RELEASE TO WAREHOUSE DATE: 19.JUL.2024. MANUFACTURING SITE: CROSSROADS EXTREMITY SYSTEMS, LLC. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 THE WIRE BROKE OFF IN THE CLAMP, AND COULDN'T BE TAKEN OUT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812003 PIN DISTRACTOR EXTRACTOR HWB SYNTHES TRAUMA : CROSSROADS EXTREMITY SYSTEMS, LLC 107198R 00810112596250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown