BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 5925328 · Received September 2, 2016

    Report

    Report Number
    1719045-2016-10663
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Report Date
    August 19, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORTED PATIENT OR SURGICAL INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. SERVICE HISTORY REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART 319.006 WITH LOT 7971080 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS APRIL 8, 2015, WHICH IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: APRIL 8, 2015. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A METAL DEPTH PROBE COMPONENT HAS BROKEN OFF OF A DEPTH GAUGE INSTRUMENT. THE ISSUE WAS DISCOVERED DURING STERILE PROCESSING AS THE DEVICE WAS DISMANTLED FOR CLEANING. THERE WAS NO REPORTED PATIENT OR PROCEDURAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575450 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES MONUMENT 7971080

    Patients

    Seq Age Sex Outcome Treatment
    1