BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMER HEAD Ø15.5

    MDR report key: 3191454 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-029456
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. SUBJECT DEVICE WAS NOT RETURNED AND NO EVALUATIONS MADE OR CONCLUSIONS DRAWN. A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS RUST ON THE DRILL HEAD. IT WAS NOT REPORTED THAT THERE WAS ANY UNTOWARD EFFECT ON ANY PATIENT OR INCREASE IN SURGICAL TIME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291462 SYNREAM REAMER HEAD Ø15.5 REAMER, ORTHOPEDIC HTO SYNTHES GMBH 18813

    Patients

    Seq Age Sex Outcome Treatment
    1