BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSOLE FOR PIEZOELECTRIC SYSTEM

    MDR report key: 4887402 · Received July 2, 2015

    Report

    Report Number
    8030965-2015-11158
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    June 24, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    DZI
    PMA / PMN Number
    PK100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A SERVICE AND REPAIR EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE CUSTOMER REPORTED THE DEVICE WAS ONLY WORKING INTERMITTENTLY. THE REPAIR TECHNICIAN REPORTED ¿ELECTRONIC CONTROL DAMAGED¿ AS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON 7-JUL-2015. THIS ITEM PASSED SYNTHES FINAL INSPECTION AND WAS RETURNED TO THE CUSTOMER ON 11-AUG-2015. THE EVALUATION WAS CONFIRMED. 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

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODES: JDX, ERL, HBE, HWE DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE SERVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW: LOT 832309.014/204497.002: A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. THE ITEM WAS PREVIOUSLY RETURNED FOR SERVICE ON (B)(4) 2012, (B)(4) 2013, (B)(4) 2014 AND THE DEVICE PASSED TESTING. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON (B)(4) 2015 AND DEVICE FAILED INSPECTION-WORKS INTERMITTENTLY. THE PREVIOUS SERVICE CONDITIONS OF DEVICE PASSED TESTING ARE NOT RELEVANT TO THE CURRENT COMPLAINED ISSUE OF DEVICE FAILED INSPECTION-WORKS INTERMITTENTLY. THE MANUFACTURE DATE OF THIS ITEM IS (B)(4) 2011. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 THAT THREE (3) DEVICE FAILED INSPECTION. ALL OF THE DEVICES ONLY WORKED INTERMITTENTLY. THERE WAS NO SURGICAL OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431002 CONSOLE FOR PIEZOELECTRIC SYSTEM DRILL, BONE, POWERED DZI SYNTHES OBERDORF 204497.002

    Patients

    Seq Age Sex Outcome Treatment
    1