BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN SPRAY KIT

    MDR report key: 5794238 · Received July 14, 2016

    Report

    Report Number
    0001526350-2016-00071
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Date of Event
    June 22, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNING TO THE MANUFACTURER FOR EVALUATION; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR PART NUMBER 00-5150-475-01, LOT 63141093. THIS DEVICE WAS MANUFACTURED AND PLACED INTO INVENTORY ON (B)(4) 2015. THERE WERE NO RELATED NON-CONFORMANCES. ENERGIZER ¿AA¿ BATTERIES PART NUMBER 06-0013-050-63 FROM LOT NUMBER 80690483 WERE USED IN THE ASSEMBLY OF THE REFERENCED PULSAVACS. THESE BATTERIES WERE CERTIFIED BY THE SUPPLIER AND PLACED INTO ZIMMER SURGICAL INVENTORY ON (B)(4) 2015. THE SHELF LIFE FOR THIS LOT WAS THROUGH 12-2025. NO NON-CONFORMANCES WERE DISCOVERED FOR BATTERIES FROM THIS LOT IN INCOMING INSPECTION OR FROM THE ASSEMBLY/TEST AREA. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. QUALITY ASSURANCE PERFORMS FUNCTIONAL AND PERFORMANCE TESTING ON A REPRESENTATIVE SAMPLE. EACH PULSAVAC DEVICE IS ALSO CYCLED THROUGH BOTH THE HIGH SPEED MODE AND LOW SPEED MODE MULTIPLE TIMES BY THE MANUFACTURING OPERATOR AS DEFINED BY THE WORK INSTRUCTIONS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO SPONTANEOUS ANOMALIES AND THE REVIEW OF THE MANUFACTURING AND TESTING PROCEDURES FOUND NO SYSTEMIC ISSUES RELEVANT TO THIS COMPLAINT. EACH PULSAVAC IS INSPECTED AND TESTED SEVERAL TIMES BEFORE PACKAGED. THE REPORTED EVENT IS REMOTE BUT THERE EXISTS A RISK POTENTIAL FOR THE BATTERY TO SPLIT OPEN AND/OR VENT. THIS HAS BEEN ADDRESSED IN THE RISK MANAGEMENT FILES. WITHOUT THE RETURNED PRODUCT FOR CONFIRMATION OF THE REPORTED EVENT AND ASCERTAINING A DEVICE FAULT A TRUE ROOT CAUSE FOR THIS REPORTED EVENT CANNOT BE DETERMINED. RECOMMENDED ACTIONS: NO RECOMMENDED ACTIONS AT THIS TIME; SEVERITY AND FREQUENCY DO NOT WARRANT FURTHER ACTIONS. ISSUE IS TRENDED BY QUALITY REPORTS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT DURING THE KIT INSPECTION (PRIOR TO SURGERY), THE DEVICE DIDN'T FUNCTION DUE TO BATTERY LEAK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED ON JUL 20, 2016 THAT AN ALTERNATE DEVICE WAS UTILIZED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449819 FAN SPRAY KIT FAN SPRAY KIT FQH ZIMMER SURGICAL, INC. N/A 63141093

    Patients

    Seq Age Sex Outcome Treatment
    1