BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T

    MDR report key: 3251178 · Received July 29, 2013

    Report

    Report Number
    8030965-2013-04496
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ADDITIONAL EVALUATION PERFORMED BY THE COMPLAINT DEPARTMENT REPORTED THE GAUGE WAS NOT MANUFACTURED TO SPECIFICATIONS. THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE GAUGE OF THIS PRODUCT WAS 2MM MORE SHORTER THAN NORMAL INSTRUMENT FROM THE LOAN SET. THE PRODUCT WAS RECEIVED AND SENT FOR INVESTIGATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353584 DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T HTJ SYNTHES GMBH 8117736

    Patients

    Seq Age Sex Outcome Treatment
    1