BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL BURR 4.0MM 5PK

    MDR report key: 8070968 · Received November 14, 2018

    Report

    Report Number
    1221934-2018-55294
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    August 17, 2018
    Report Date
    November 14, 2018
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HRX
    UDI-DI
    10886705022045
    PMA / PMN Number
    K041824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CORRECTION: UPON FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED THAT THE REPORTED MALFUNCTION IS UNLIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WERE TO RECUR. THEREFORE, THIS COMPLAINT IS NOT REPORTABLE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI: (B)(4) - INCOMPLETE THE LOT NUMBER IS CURRENTLY UNAVAILABLE; THEREFORE, THE EXP DATE IS UNAVAILABLE. THE COMPLAINT WAS RECEIVED AND EVALUATED WITH NPD. VISUALLY THE DEVICE SEEM TO BE IN GOOD CONDITION, DEVICE SEEMS UNUSED. NO OBVIOUS ANOMALIES FOUND. FUNCTIONALLY, WHEN ROTATING THE INNER BLADE FRICTION WAS FELT. THE INNER BLADE WAS INSPECTED, SCRATCH MARKS WERE FOUND ON THE INNER HUB. WHEN INSPECTING THE OUTER HUB ON THE INSIDE, A WHITE SUBSTANCE WAS FOUND, NPD CONFIRMS THIS IS THE CAUSE FOR THE FRICTION THAT OCCURS IN THE INNER AND OUTER HUBS WHEN THE TWO BLADES ARE ASSEMBLED TOGETHER. THE SUBSTANCE COULD NOT BE IDENTIFIED, THERE A POSSIBLE ROOT CAUSE COULD NOT BE DETERMINED. AT HIGH RPMS WHEN DEVICE IS USED IN THE FIELD THE REPORTED FAILURE COULD OCCUR. THIS COMPLAINT IS CONFIRMED. FURTHERMORE, NO LOT NUMBER WAS SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM AND AT THIS TIME NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SURGEON RECOGNIZED THAT THERE WAS AN ABNORMAL METAL NOISE WHEN DRILLING THE PATIENT¿S BONE DURING ARCR SURGERY. THEN, THE ERROR MESSAGE WAS DISPLAYED AND STOPPED WORKING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THERE WAS A WHITE SUBSTANCE WHEN INSPECTING THE OUTER HUB ON THE INSIDE OF THE BLADE ON THE DEVICE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED BY USING ALTERNATIVE DEVICE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS BRAND NEW AND ON ITS FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909964 BARREL BURR 4.0MM 5PK  ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE HRX DEPUY MITEK LLC US 10886705022045

    Patients

    Seq Age Sex Outcome Treatment
    1