BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE ORIENTATION GUIDE

    MDR report key: 21123250 · Received January 10, 2025

    Report

    Report Number
    1818910-2025-00583
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 18, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    PXH
    UDI-DI
    10603295116592
    PMA / PMN Number
    K170748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: PLASTIC PART OF THE INSERTER IS BROKEN. THE PRODUCT WAS RETURNED TO MEDTECH ORTHOPAEDICS FOR EVALUATION. VISUAL INSPECTION REVEALED THE WHITE TIP BROKEN AND THE METAL PRONG SLIGHTLY BENT FROM THE GLENOSPHERE ORIENTATION GUIDE. BROKEN FRAGMENT WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, DEVICE EXHIBITED SIGNS OF NORMAL USAGE. EVEN THOUGH THERE IS NO CERTAINTY WHICH CONDITION HAPPENED FIRST, POTENTIAL CAUSE CAN BE ATTRIBUTED TO UNINTENDED USE ERROR BY USE OF EXCESSIVE FORCE IN A PRYING MOTION AND OVERLOADING THE MATERIAL. PROPERLY HANDLING AND¿ATTENTION TO THE APPROVED USE OF THE DEVICE DIMINISHES THE RISK OF FAILURE. 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. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE GLENOSPHERE ORIENTATION GUIDE WOULD HAVE CONTRIBUTED TO A DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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 PLASTIC PART OF THE INSERTER IS BROKEN. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364916 GLENOSPHERE ORIENTATION GUIDE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES PXH DEPUY ORTHOPAEDICS INC US 5521368 10603295116592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown