BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 4141492 · Received October 4, 2014

    Report

    Report Number
    2530088-2014-10297
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. SERVICE HISTORY REVIEW: LOT #4694002 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS 17-DEC-2003. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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 BY THE SERVICE AND REPAIR DEPARTMENT THAT THE NEEDLE FOR THE DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS BROKE OFF. THE DEVICE DID NOT MALFUNCTION DURING SURGERY WHILE BEING USED ON PATIENT. IT WAS REPORTED THAT THE NEEDLE BROKE WHILE IN THE WASH, HOWEVER, THE BROKEN PIECE WAS NOT FOUND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621590 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE,DEPTH HTJ SYNTHES BRANDYWINE 4694002

    Patients

    Seq Age Sex Outcome Treatment
    1