BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR SMALL SCREWS

    MDR report key: 4137846 · Received October 3, 2014

    Report

    Report Number
    1719045-2014-10491
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HTJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE HISTORY REVIEW: LOT 2144718/5140775: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. 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

    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. A SERVICE HISTORY REVIEW HAS BEEN REQUESTED. 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

    THE SERVICE AND REPAIR DEPARTMENT DOCUMENTED THAT TWO DEPTH GAUGES FOR SMALL SCREWS; PART # (B)(4), IS MISSING TIPS. THE DEVICES WERE FOUND DISASSEMBLED AFTER THE STERILE WASH. THE INSTRUMENT WAS USED IN SURGERY A BUT THERE WAS NO ISSUE DURING ANY PROCEDURE OR ANY IMPACT TO A PATIENT OR A DELAY. THIS REPORT IS FOR 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620064 DEPTH GAUGE FOR SMALL SCREWS DEPTH GAUGE HTJ SYNTHES OBERDORF 2144718

    Patients

    Seq Age Sex Outcome Treatment
    1