BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMING ROD Ø2.5 SHORT L950

    MDR report key: 3173849 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03435
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    June 28, 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

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE SHAFT IS BROKEN. UNFORTUNATELY WE CANNOT ESTABLISH THE CAUSE FOR THE BREAK WITHOUT FURTHER INFORMATION. IT COULD BE ASSUMED THAT AN ACCIDENTAL BENDING MOMENT WHICH EXCEEDED THE MATERIALS MAXIMUM LOAD LEAD TO THE BREAKAGE. AS THE COUPLING PIECE OF THE DRILL HEAD ATTACHMENT IS IN EXCELLENT CONDITION IT SHOWS US THAT THE DRILL WAS CORRECTLY POSITIONED/ATTACHED. THE EXACT DAMAGE CAN THEREFORE NOT BE DUE TO THE SHAFT. THE HOMOGENOUS BREAK CHARACTERISTIC SHOWS A PERFECT MATERIAL QUALITY. NO PRODUCT FAULT COULD BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SHAFT OF THE REAMING ROD BROKE DURING THE OPERATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273544 SYNREAM REAMING ROD Ø2.5 SHORT L950 HTO SYNTHES GMBH 5908395

    Patients

    Seq Age Sex Outcome Treatment
    1