BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS GLENS 2 PRONG INS/IMP

    MDR report key: 5156253 · Received October 16, 2015

    Report

    Report Number
    0001825034-2015-04329
    Event Type
    Injury
    Date Received
    October 16, 2015
    Date of Event
    September 23, 2015
    Report Date
    November 12, 2015
    Manufacturer
    BIOMET SET
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING OF INSTRUMENTS, NUMBER 1 STATES, ¿SURGICAL INSTRUMENTS AND INSTRUMENT CASES ARE SUSCEPTIBLE TO DAMAGE FOR A VARIETY OF REASONS INCLUDING PROLONGED USE, MISUSE, ROUGH OR IMPROPER HANDLING. CARE MUST BE TAKEN TO AVOID COMPROMISING THEIR EXACTING PERFORMANCE.¿

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. EVALUATION DETERMINED PRODUCT LIKELY FAILED DUE TO MISUSE, BY BEING PUT THROUGH EXTENSIVE USE AND/OR EXCESSIVE FORCE. PRODUCT SHOWS SIGNS OF HEAVY WEAR AND TEAR FROM BEING IN USE SINCE 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY ON (B)(6) 2015. DURING THE PROCEDURE, A SCREW FELL FROM THE END OF THE GLENOSPHERE INSERTER. THE SCREW WAS RETRIEVED FROM THE PATIENT AND IT WAS VERIFIED NO OTHER PIECES WERE REMAINING IN THE PATIENT. A SECONDARY IMPACTOR WAS AVAILABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686798 COMP RVS GLENS 2 PRONG INS/IMP INSTRUMENT, MANUAL LXH BIOMET SET N/A 069680

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention