BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTND 145 RSA IMPLANT INSERTER

    MDR report key: 22003168 · Received May 12, 2025

    Report

    Report Number
    1818910-2025-07603
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 21, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    PHX
    UDI-DI
    10603295518785
    PMA / PMN Number
    K192855
    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 (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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE SPD INFORMED REP THAT INSTRUMENT BROKE WHILE BEING WASHED. THE EVENT DID NOT HAPPEN IN SURGERY. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE XTND 145 RSA IMPLANT INSERTER WAS BROKEN AT THE MIDDLE SECTION OF THE BODY INSERTER. THE BROKEN FRAGMENT WAS RETURNED FOR EVALUATION. ADDITIONALLY SIGNS OF EXTENSIVE AND REPEATED USE CAN BE SEEN ON THE WHOLE SURFACE. THE POTENTIAL CAUSE COULD BE ATTRIBUTED BY A COMBINATION OF HEAVY USE, UNINTENDED IMPACTION FORCES IN AREAS THAT ARE NOT INTENDED TO BE IMPACTED. DUE TO THE LOW FREQUENCY OF THIS OCCURRENCES AND NOT SUSPECTING ANY DESIGN ISSUE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL INSPECTION WAS NOT PERFORMED AS IT IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE XTND 145 RSA IMPLANT 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 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. H11 ADDITIONAL NARRATIVE: CORRECTED: H3.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE PROCESSING DEPARTMENT INFORMED THAT THE INSTRUMENT BROKE WHILE BEING WASHED. THE EVENT DID NOT HAPPEN IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393706 XTND 145 RSA IMPLANT INSERTER DRILL GUIDES PHX DEPUY IRELAND - 9616671 FE2081771 10603295518785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown