BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø11 F/PFNA BLADE

    MDR report key: 3211194 · Received July 8, 2013

    Report

    Report Number
    8030965-2013-04239
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THE INVESTIGATION HAS SHOWN THAT THE COUPLING PART OF THE REAMER IS BROKEN OFF AS COMPLAINED. THE COMPLAINED INSTRUMENT PRESENTS SIGNS OF FREQUENTLY USE. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN JANUARY 2009 ACCORDING TO THE SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. BASED ON THESE RESULTS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE HAVE TO INDICATIVE THAT MECHANICAL FORCE IN COMBINATION WITH WEAR AND TEAR LED TO THE BREAKAGE OF THE COUPLING PART. THIS INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATION. BECAUSE OF NO ORIGINAL FAULT AND CONSIDERING THE AGE OF THIS ARTICLE WE REGRETTABLY CANNOT REPLACE IT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE OPERATION THE INSTRUMENT BROKE. THERE WAS NO IMPACT ON THE PROCEDURE. THE OPERATION WAS FINISHED SUCCESSFULLY. THE BROKEN PART WAS THROWN AWAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310457 REAMER Ø11 F/PFNA BLADE HTO SYNTHES GMBH 417635

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR