BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER

    MDR report key: 20175728 · Received September 9, 2024

    Report

    Report Number
    8030965-2024-11028
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    10886982271075
    PMA / PMN Number
    K172157
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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. H3, H6: PART: 03.033.003-US. LOT: 78P5634. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE: 16-FEBRUARY-2021. A DEVOICE HISTORY RECORD (DHR) EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE ARTICLE 03.033.003-US LOT 78P5634, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE RECEIVED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT RAD AIMING ARM/FRN GREATER TROCHANTER (03.033.003) HAD BROKEN. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE RAD AIMING ARM/FRN GREATER TROCHANTER WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, POTENTIAL CAUSE CAN BE ATTRIBUTED TO COMPONENT FAILURE 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 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. 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 ON AN UNKNOWN DATE THE WHITE TABS ON THE GREAT TROCHANTER RADIOLUCENT AIMING ARM FOR FRN BROKE OFF. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330905 RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 78P5634 10886982271075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown