BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM/ RADIOLUCENT

    MDR report key: 16643346 · Received March 30, 2023

    Report

    Report Number
    8030965-2023-03854
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    10886982297396
    PMA / PMN Number
    K201336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. H10 ADDITIONAL NARRATIVE: D9 H3, H4 H6: PART #: 03.043.029 LOT #: 2024220 MANUFACTURING SITE: WERK SELZACH SUPPLIER: CREATEC GMBH & CO. KG RELEASE TO WAREHOUSE DATE: 22 MAR 2021 EXPIRATION DATE: N/A A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE LATCH OF AIMING ARM/ RADIOLUCENT, P/N: 03.043.029, LOT: 2024220, WAS CRACKED. THE OBSERVED DAMAGE WAS LOCATED AROUND THE PIN. NO OTHER PROBLEM 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 AIMING ARM/ RADIOLUCENT WAS CRACKED ACROSS THE LATCH PIN SECTION. BREAKAGE OF THE DEVICE CANNOT BE CONFIRMED AS IT REMAINS IN ONE PIECE. DURING THE ANALYSIS OF THE COMPLAINTS TWO SUBCATEGORIES OF THE AIMING ARM (03.043.029) LATCH 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 AIMING ARM/ RADIOLUCENT 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 AIMING ARM/ RADIOLUCENT 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. 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. G1 MANUFACTURING SITE NAME AND ADDRESS

    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. ADDITIONAL NARRATIVE: REPORTER IS A J&J EMPLOYEE. THE SUBJECT DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 TIBIAL NAIL AIMING ARM SNAPPED AS THE ARM WAS BEING REMOVED DURING SURGERY. THERE WAS ZERO DELAY WITH THE SURGERY. THE AIMING ARM IS NO LONGER WORKING AND WILL NEED A REPLACEMENT. 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
    177682 AIMING ARM/ RADIOLUCENT SCREW, FIXATION, BONE HWC SYNTHES GMBH 03.043.029 2024220 10886982297396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown