BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM RADIOLUC

    MDR report key: 16939776 · Received May 16, 2023

    Report

    Report Number
    8030965-2023-06201
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    May 1, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07612334171108
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. PART : 03.043.029. LOT: 2024221 (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE AIM-ARM RADIOLUC HAD BOTH OF THE HOOKS FROM THE LATCH BROKEN, ONLY 1 OF THE HOOKS BROKEN FRAGMENT WAS RETURNED. DURING THE ANALYSIS OF THE COMPLAINTS TWO SUBCATEGORIES OF THE AIMING ARM LATCH, DRAWING FAILURE WERE IDENTIFIED. THE FAILURE IS A BREAKAGE OF THE CARBON-FIBER REINFORCED LATCH. THE FAILURE MODE IS AN INTERLAMINAR BREAKAGE DUE TO SHEAR FORCES. BREAKAGE IS MOST LIKELY FAVORED BY DEFECTS IN THE STRUCTURE OF THE CARBON FIBER REINFORCED PEEK PLATE. IT IS IN THE NATURE OF THE MATERIAL THAT THE SHEAR STRENGTH IS HIGHLY ANISOTROPIC AND LOWEST BETWEEN CARBON FIBER LAYERS. LIKELY INTERLAMINAR SHEAR STRENGTH IS REDUCED BY DEFECTS RESULTING FORM MANUFACTURING ISSUES NOT LEADING TO COMPLETE BOND BETWEEN THE CARBON LAYERS. A DIMENSIONAL INSPECTION FOR THE AIM-ARM RADIOLUC WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE AIM-ARM RADIOLUC WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED: THE FOLLOWING DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: AIMING ARM, RADIOLUCENT REV. (CURRENT) / REV. G (MANUFACTURED) DIMENSIONAL INSPECTION: N/A. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP

    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. H10 ADDITIONAL NARRATIVE: D2B: ADDITIONAL PRODUCT CODE: JDS. D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J SALES REPRESENTATIVE. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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, THERE WAS A TIBIAL NAIL ADVANCED CASE AS THE SURGEON WENT TO ADVANCE THE NAIL FURTHER EXTRACTED, THE DRIVING CAP WITH TWO HOOKS AIMING ARM SNAPPED OFF. ONE OF THE HOOKS WAS LOCATED ON THE FLOOR AND THE SECOND HOOK COULDN'T BE LOCATED. THE INITIAL CONCERN WAS THAT THE HOOK MIGHT BE INSIDE THE PATIENT, BUT MIGHT BE IN THE INCISION SUPRA PATELLAR AND NAIL IN CANAL. THE INSPECTION WAS DONE AND NOTHING WAS FOUND. THE CASE WAS COMPLETED SUCCESSFULLY. ALTHOUGH THERE WAS AN INITIAL DOUBT ABOUT THE AIMING ARM HOOK OUT ON, SO WERE CONDUCTED APPROX. WITH DISTAL OF THE CASE WERE INCLUDED. THE RECEIVING NUMBER FOR THIS EVENT IS 72761. THE ITEM IN QUESTION IS THE AIMING ARM TO THE TIBIAL NAIL ADVANCED. A REPLACEMENT ITEM IS NEEDED AS SOON AS POSSIBLE. CONCOMITANT PRODUCT DETAILS: UNK - NAILS: TFNA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN). THIS REPORT IS FOR ONE (1) AIMING ARM/ RADIOLUCENT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864477 AIM-ARM RADIOLUC SCREW, FIXATION, BONE HWC SYNTHES GMBH 03.043.029 2024221 07612334171108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - NAILS: TFNA