BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTARY MIXER

    MDR report key: 5910451 · Received August 29, 2016

    Report

    Report Number
    1719045-2016-10646
    Event Type
    Malfunction
    Date Received
    August 29, 2016
    Report Date
    August 15, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    K011897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE AND REPAIR EVALUATION WAS PERFORMED: THE CUSTOMER REPORTED THE HINGE WAS BROKEN. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON 27-SEP-2016. THE VENDOR REPORTED THE HINGES WERE BROKEN. THE VENDOR REPLACED THE HINGES, READJUSTED THE LID, AND REPLACED THE BATTERY PER THE VENDOR WORK INSTRUCTIONS. THE DEVICE WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. ATTACHED SERVICE RECORD ROUTER COMPLETED THROUGH OPERATION 21. THE COMPONENT WAS REPAIRED AND TESTED TO OPERATIONAL SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO CAUSE WAS OBSERVED; NO MANUFACTURING OR DESIGN ISSUES WERE NOTED. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE EVALUATION WAS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A SERVICE HISTORY OF THE PAST THREE YEARS FOR PART NUMBER MXR-US-2000 WITH LOT NUMBER(S) N001408/SERIAL NUMBER (B)(4) HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THE ITEM HAS NOT PREVIOUSLY BEEN SENT IN FOR SERVICE. THERE IS NO RELEVANT INFORMATION TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS FEBRUARY 17, 2004. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. PART MXR-US-2000, LOT N001408: RELEASE TO WAREHOUSE DATE: FEBRUARY 13, 2004. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ROTARY MIXER HINGE WAS JUST FOUND BROKEN; DEVICE IS PART OF FIELD EQUIPMENT. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT, BUT IT IS UNKNOWN HOW OR WHEN THE BREAK OCCURRED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563439 ROTARY MIXER FILLER, CALCIUM SULFATE PREFOR MED PELLETS MQV SYNTHES MONUMENT N001408

    Patients

    Seq Age Sex Outcome Treatment
    1