BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/STAT+DYN DIST LOCK

    MDR report key: 21816237 · Received April 10, 2025

    Report

    Report Number
    8030965-2025-03505
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 14, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) 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: H3, H6: PART NUMBER: 03.037.113 LOT NUMBER: 35P7561 MANUFACTURING SITE: HÄGENDORF RELEASE TO WAREHOUSE DATE: 02-APR-2020 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION OF " 03.037.113, AIM-ARM 130° F/STAT+DYN DIST LOCK" CAN NOT REVEALED THE REPORTED CONDITION. AS, THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF UNABLE TO ASSEMBLE OR DISASSEMBLE. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED, A DIMENSIONAL INSPECTION CANNOT BE PERFORMED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE AIM-ARM 130° F/STAT+DYN DIST LOCK WOULD NOT CONTRIBUTE 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 COMPLAINT CONDITION. AS PART OF 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. 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 DURING THE SURGICAL PROCEDURE, AT THE TIME OF ATTEMPTING TO DISASSEMBLE (AFTER IMPLANTATION OF THE SPIRAL BLADE), THE YELLOW GUIDE SHEATH, MOUNTED WITH THE BRA NUT AND COMPRESSION OF THE DIRECTIONAL ARM 130, IT WOULD NOT DISASSEMBLE. THE SHEATH WAS COMPLETELY BLOCKED. THEY TRIED TO DISASSEMBLE ACCORDING TO SURGICAL TECHNIQUE BY ACTIVATING THE ARM LEVER AND TURNING THE NUT AND IT WAS NOT POSSIBLE. THIS CAUSED DELAY IN THE PROCEDURE WHICH MEANT THAT THE PATIENT REQUIRED MORE DOSES OF ANESTHETIC MEDICATION AND THE DISTAL BLOCK HAD TO BE PERFORMED FREEHAND SINCE THE GUIDE SHEATH COULD NOT BE REMOVED FROM THE DIRECTIONAL ARM AND IT WAS NOT POSSIBLE TO DO IT DIRECTLY FROM THE ARC SINCE THE YELLOW GUIDE SHEATH PREVENTED THE SLIDING OF THE DISTAL BLOCKAGE GUIDES. THIS GUIDE WAS RETURNED BASED, ASSEMBLED AND MOUNTED ON THE DIRECTIONAL ARM ON THE INSTRUMENTAL TRAY. ADDITIONALLY THE KEY ROD REFERENCE IS TWISTED WHEN TRYING TO RELEASE THE ARCH GUIDE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471807 AIM-ARM 130° F/STAT+DYN DIST LOCK GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 35P7561

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown