BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PIECE FOR PIEZOELECTRIC SYSTEM

    MDR report key: 4259676 · Received November 18, 2014

    Report

    Report Number
    2520274-2014-14797
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Report Date
    October 24, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDX
    PMA / PMN Number
    PK100410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT PREVIOUSLY BEEN IN FOR SERVICE. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. THE MANUFACTURE DATE OF THIS ITEM IS 16-NOV-2012. 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.

    Additional Manufacturer Narrative · 1

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DEVICE WAS NOT WORKING. THE REPAIR TECHNICIAN REPORTED THE CORD HAD A BREAK IN IT. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR. THIS ITEM PASSED SYNTHES FINAL INSPECTION AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF PACKAGING. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED 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 HAND PIECE FOR THE PIEZOELECTRIC IS NOT WORKING. IT IS UNKNOWN WHAT THE CAUSE IS. THE MALFUNCTION DID NOT OCCUR DURING SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745775 HAND PIECE FOR PIEZOELECTRIC SYSTEM INSTRUMENT, SURGICAL, SONIC AND ACCESSORY/ATTACHMENT JDX SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1