BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANTIS PERSUADER

    MDR report key: 3542729 · Received December 30, 2013

    Report

    Report Number
    0009617544-2013-00532
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 10, 2013
    Report Date
    December 10, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE JAMMED MANTIS PERSUADER WAS CONFIRMED BASED ON THE COMPLAINT INFORMATION PROVIDED AT INTAKE. THE MANUFACTURING RECORD FOR THE REPORTED LOT (093217) WAS REVIEWED, BUT THERE WERE NO MANUFACTURING ISSUES RELEVANT TO THE ISSUE. THE PRODUCT ISSUE OCCURRED DURING SURGERY CAUSING A 30 MINUTE SURGICAL DELAY, BUT WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SURGEON COMPLETED THE SURGERY SUCCESSFULLY WITHOUT THE USE OF THE PERSUADER. THE RETURNED PRODUCT UPON INSPECTION, WAS CONFIRMED TO BE FUNCTIONAL. BASED ON THE NATURE OF THE FAILURE MODE THE MOST LIKELY REASON FOR THE INSTRUMENT MALFUNCTION IS A LACK OF LUBRICATION THAT LED TO THE SEIZURE OF THE DEVICE. THE SALES REP CONFIRMED THAT THE INSTRUMENT WAS LUBRICATED PRIOR TO USE. THE CAUSE OF THE LOSS OF LUBRICATION BETWEEN SET PREP AND SURGERY IS UNKNOWN, BUT IS LIKELY RELATED TO THE CLEANING AND STERILIZATION PROCESS. THE MARKING ON THE DEVICE CLEARLY STATES TO LUBRICATE THE DEVICE PRIOR TO USE AND THIS INFORMATION IS ALSO INDICATED IN THE INSTRUMENT IFU. CONCLUSION: THE RETURNED PRODUCT WAS CONFIRMED TO BE FUNCTIONAL AND BASED ON THE NATURE OF THE FAILURE, MOST LIKELY MALFUNCTIONED DUE TO LACK OF LUBRICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED "DURING PREPARATION BEFORE THE SURGERY, THE SPRING IN THE HANDLE JUMPED OUT. ANOTHER HANDLE WAS AVAILABLE IN THE KIT AND WAS USED FOR THE SURGERY. ALSO, WHEN TAKING THE PERSUADER, THE SURGEON OBSERVED THAT THE PERSUADER WAS TOTALLY SEIZED. THE SURGEON WORKED ON LEVELS L4 AND L5, WITHOUT THE USE OF THE PERSUADER, AND MANAGED TO COMPLETE THE PROCEDURE SUCCESSFULLY. DUE TO THIS EVENT, THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES, BUT NO IMPACT OR ADVERSE CONSEQUENCES FOR THE PATIENT."

    Description of Event or Problem · 1

    IT WAS REPORTED "DURING PREPARATION BEFORE THE SURGERY, THE SPRING IN THE HANDLE JUMPED OUT. ANOTHER HANDLE WAS AVAILABLE IN THE KIT AND WAS USED FOR THE SURGERY. ALSO, WHEN TAKING THE PERSUADER, THE SURGEON OBSERVED THAT THE PERSUADER WAS TOTALLY SEIZED. THE SURGEON WORKED ON LEVELS L4 AND L5, WITHOUT THE USE OF THE PERSUADER, AND MANAGED TO COMPLETE THE PROCEDURE SUCCESSFULLY. DUE TO THIS EVENT, THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES, BUT NO IMPACT OR ADVERSE CONSEQUENCES FOR THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679575 MANTIS PERSUADER INSTRUMENT-ROD PERSUADER LXH STRYKER SPINE-FRANCE 093217

    Patients

    Seq Age Sex Outcome Treatment
    1