BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIS BROACH SIZE 5

    MDR report key: 23605985 · Received November 20, 2025

    Report

    Report Number
    1818910-2025-20424
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    September 23, 2025
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    QBO
    UDI-DI
    10603295548645
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    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 (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. ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE POST BROKEN IN HALF. BROKEN PIECE WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, SIGNS OF USAGE WERE OBSERVED ON THE OVERALL DEVICE SURFACE. NO OTHER COSMETIC ANOMALY WAS NOTED. POTENTIAL CAUSE FOR THE BREAKAGE OBSERVED CAN BE ATTRIBUTED TO UNINTENDED USE ERROR BY USE OF EXCESSIVE FORCE WHILE TRIALING THAT OVERLOAD THE DEVICE MATERIAL. PROPERLY HANDLING AND ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. AS PER KINCISE¿ SURGICAL AUTOMATED SYSTEM ¿ INSTRUCTIONS FOR USE, PAGE 11, THE FOLLOWING PRECAUTIONS NEED TO BE FOLLOWED FOR THE KINCISE ADAPTER ATTACHMENT AND THE BROACH ASSEMBLY/DISASSEMBLY PROCESS: 1) FULLY SEAT GUIDE PINS INTO THE CORRESPONDING LOCATOR OPENING OF EACH ADAPTER; 2) USING AN APPROVED BROACH, INSERT THE BROACH PIN INTO THE BROACH ADAPTER LOCATOR WHILE ALSO ALIGNING THE BROACH ADAPTER GUIDE PIN WITH THE LOCATOR OPENING ON THE BROACH; 3) WHILE HOLDING THE ADAPTER IN PLACE, PULL THE BROACH IN MULTIPLE DIRECTIONS TO VERIFY A SECURE, LOCKED CONNECTION TO THE ADAPTER. ALSO, VERIFY THE LOCKING LATCH OF THE DEVICE REMAINS CLOSED; 4) IF THE ADAPTER IS ATTACHED TO THE SURGICAL IMPACTOR, ENSURE THE BATTERY HAS BEEN REMOVED BEFORE PROCEEDING TO RAISE THE LOCKING LATCH TO THE FULLY OPEN POSITION TO REMOVE BROACH. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL TEST WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE, AND AS MATING COMPONENT WAS NOT RETURNED FOR EVALUATION. WITH EVIDENCE PROVIDED, THE REPORTED JAMMED CONDITION CANNOT BE CONFIRMED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ACTIS BROACH SIZE 5 WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE 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 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 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 5 ACTIS BROACH WAS GETTING STUCK TO KINCISE ATTACHMENT AND NECK TRIAL WOULDN¿T COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262060 ACTIS BROACH SIZE 5 HIP INSTRUMENT - BROACH QBO DEPUY IRELAND - 3015516266 PG345868 10603295548645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown