BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIS BROACH SZ 7

    MDR report key: 21858155 · Received April 17, 2025

    Report

    Report Number
    1818910-2025-05690
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 21, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HTQ
    UDI-DI
    10603295393696
    PMA / PMN Number
    K150862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    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 ACTIS BROACH SZ 7 HAD SIGNS OF REPEATED USE. A SLIGHT DEFORMATION ON THE SURFACE WAS FOUND ON THE ATTACHMENT AREA. NO OTHER DAMAGE WAS OBSERVED. A FUNCTIONAL TEST WAS PERFORMED USING A LABORATORY SAMPLE MATING DEVICE, AND THE ACTIS BROACH SZ 7 COULD NOT BE FULLY ASSEMBLED. THE INABILITY TO ASSEMBLE WAS ATTRIBUTED TO THE CONDITION OF THE ATTACHMENT AREA. THE OBSERVED CONDITION OF THE DEVICE APPEARS CONSISTENT WITH A RANDOM COMPONENT FAILURE POTENTIALLY CAUSED BY EXPOSURE TO UNINTENDED FORCES. THESE FORCES COULD INCLUDE REPEATED IMPACTIONS APPLIED WHILE THE DEVICE WAS NOT FULLY SEATED OR WAS MISALIGNED OFF-AXIS WITH ITS MATING DEVICE, 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 ACTIS BROACH SZ 7 WOULD HAVE CONTRIBUTED TO THE COMPLAINED 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 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: 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 BARB ON PROXIMAL BROACH. IT WILL NOT ENGAGE ON HANDLE. THERE WAS NO ADVERSE CONSEQUENCES AND NO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764063 ACTIS BROACH SZ 7 BROACHES HTQ DEPUY IRELAND - 9616671 PG308828 10603295393696

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male