BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTARY MIXER

    MDR report key: 5645614 · Received May 10, 2016

    Report

    Report Number
    1719045-2016-10383
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Report Date
    April 25, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MQV
    PMA / PMN Number
    PK011897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE HISTORY EVALUATION WAS PERFORMED. THE CUSTOMER REPORTED THE HINGE ON THE MACHINE WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THAT BOTH OF THE HINGES WERE BROKEN, AND THE LEGS ON THE BOTTOM WERE LOOSE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON (B)(6) 2016. THE VENDOR REPORTED THE HINGES WERE BROKEN, AND THE COUNTER WAS NOT WORKING. THE VENDOR REPAIRED THE DEVICE 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 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. DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A SERVICE HISTORY EVALUATION/REVIEW WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: A SERVICE HISTORY REVIEW OF THE PAST THREE YEARS FOR PART NUMBER (B)(4) WITH LOT NUMBER(S) 01614/N001614 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 16-MAR-2004. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART NUMBER: (B)(4) SYNTHES LOT NUMBER: N001614, RELEASE TO WAREHOUSE DATE: 11-MAR-2004, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED QUANTITY ONE (1) OF THE HINGES IS BROKEN ON THE MIXER. STERILIZATION MANAGER CONFIRMED NO PATIENT INVOLVEMENT OR PROCEDURE. DURING THE CLEANING PROCESS IT WAS NOTED THAT THE HINGES WERE BROKEN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299961 ROTARY MIXER FILLER, CALCIUM SULFATE PREFORMED PELLETS MQV SYNTHES MONUMENT N001614

    Patients

    Seq Age Sex Outcome Treatment
    1