BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOSPHERE INSERTER TIP

    MDR report key: 18217221 · Received November 28, 2023

    Report

    Report Number
    1818910-2023-24091
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Report Date
    November 28, 2023
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    LXH
    UDI-DI
    10603295547266
    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

    PRODUCT COMPLAINT (B)(4). B3: DATE OF EVENT IS AN UNKNOWN DATE. INVESTIGATION SUMMARY THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT PRODUCT CODE: 620510101, LOT NO - 176275 TRACKING NO (B)(4). PRODUCT CODE: 650011104, LOT NO - 202693 TRACKING NO (B)(4). HOWEVER, IT COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE. THIS COMPLAINT INVOLVES TWO(2) DEVICES. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE GLENOSPHERE INSERTER TIP THREADED TIP OF THE ROD HAS STRIPPED. NO OTHER ISSUES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST MANUFACTURING DAMAGE. THE POTENTIAL CAUSE WAS ATTRIBUTED TO A COMBINATION OF UNINTENDED USE ERROR AND HEAVY HANDLING FORCES OF THE DEVICES. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE GLENOSPHERE INSERTER TIP WOULD CONTRIBUTE TO THE DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO UNINTENDED USER 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 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 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. 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.

    Description of Event or Problem · 0

    THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT- PRODUCT CODE: 650011104, LOT NO - 202693. HOWEVER, IT COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE GLENOSPHERE INSERTER TIP THREADED TIP OF THE ROD HAS STRIPPED. NO OTHER ISSUES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523779 GLENOSPHERE INSERTER TIP JRN : INSERTION DEVICES LXH DEPUY IRELAND - 3015516266 202693 10603295547266

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown