BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SPACER BASE

    MDR report key: 18735564 · Received February 19, 2024

    Report

    Report Number
    1818910-2024-03705
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    February 15, 2024
    Report Date
    February 19, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HWT
    UDI-DI
    10603295395386
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, 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

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : ACCORDING TO THE INFORMATION RECEIVED, ¿IT WAS REPORTED THAT THE CONNECTING JUNCTION OF THE INSTRUMENT SNAPPED.¿ 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 ATTUNE SPACER BASE HAS THE CENTRAL POST BROKEN OFF. THE BROKEN FRAGMENT AND SNAP RING THAT ATTACHES TO THE POST WERE NOT RETURNED FOR EVALUATION. NO OTHER DEFECTS WERE OBSERVED. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATEDLY LEVERAGING THE DEVICE APART USING ANOTHER INSTRUMENT IN A PRYING MOTION CAUSING THE MATERIAL TO WEAKEN OVER TIME AND EVENTUALLY FAIL. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE, PER THE ATTUNE KNEE SYSTEM SURGICAL TECHNIQUE (107574-200827), DIMINISHES THE RISK OF FAILURE. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE SPACER BASE WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USER ERROR, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. 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. DEVICE HISTORY LOT : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. H3.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTING JUNCTION OF THE INSTRUMENT SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509821 ATTUNE SPACER BASE ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS HWT DEPUY IRELAND - 9616671 BFA0WLV 10603295395386

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown