BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 340

    MDR report key: 22663191 · Received July 30, 2025

    Report

    Report Number
    8030965-2025-07728
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 11, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07612334211682
    PMA / PMN Number
    K233696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. H11 ADDITIONAL NARRATIVE: ADDED: H4. H3, H6: THE PHOTO WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE FILM OF THE OUTER PACKAGE WAS DAMAGE. THE RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 340 WAS NOT OBSERVED IN THE PICTURE, THEREFORE; IS NOT POSIBLE CONFIRM IF THE DEVICE IS DEFORMED/BENT OR PRESENT ANOTHER CONDITION WITH THE EVIDENCE PROVIDED. ONCE THE PRODUCT LEAVES J&J MEDTECH ORTHOPAEDICS CONTROL, IT IS UNKNOWN WHAT ENVIRONMENT CONDITIONS THE PACKAGED PRODUCTS ARE EXPOSED TO DURING THAT TIME. THEREFORE THE SUSPECTED CAUSE IS TRACED TO TRANSPORT/STORAGE OUTSIDE OF J&J MEDTECH ORTHOPAEDICS CONTROL. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED FOR RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 340 . THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW ==> PART:04.233.434S LOT:6506P77. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 07 JUN 2023. EXPIRATION DATE: 01 JUN 2028. 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.

    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: D10 (CONCOMITANT) CORRECTED: E1 (INITIAL REPORTER FIRST NAME, LAST NAME), G1 (MANUFACTURING SITE NAME) 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 GUIDE WAS FOLDED WHEN IT WAS USED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444512 RETROGR FEM NAIL ADV - RFN-ADV Ø14 L 340 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 6506P77 07612334211682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SYNREAM REAMING ROD ø2.5 SHORT L950