BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE SYSTEM IMPACTOR

    MDR report key: 21666608 · Received March 21, 2025

    Report

    Report Number
    1818910-2025-04350
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 4, 2025
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWA
    UDI-DI
    10603295493549
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, 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: INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE ATTUNE SYSTEM IMPACTOR WAS FOUND CHIPPED ON THE EDGES AND DISTAL SECTION. ADDITIONALLY, DEEP SCRATCHES CAN BE SEEN ON THE IMPACTION AREA. THE OBSERVED CONDITION OF THE DEVICE APPEARS TO BE CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES SUCH AS REPEATED OFF-AXIS IMPACTIONS AND OTHER TOOLS AND HARD EDGES COMING IN CONTACT WITH THE DEVICE. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. A FUNCTIONAL TEST WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE SYSTEM IMPACTOR WOULD HAVE CONTRIBUTED TO A DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USE ERROR, AND 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 REPORTED COMPLAINT CONDITION. 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 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. 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 OFFSET BLACK REAMER HANDLE AND SHAFT X2, SYSTEM IMPACTOR, FIRE HYDRANT (PRIMARY RESECTIONS ATTACHES CUT GUIDE TO ROD), EMPH STRAIGHT HANDLE. DID NOT HAPPEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797534 ATTUNE SYSTEM IMPACTOR IMPACTORS HWA DEPUY ORTHOPAEDICS INC US BFA1JHJ 10603295493549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown