BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø11 F/PFNA BLADE

    MDR report key: 3171392 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03392
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    June 7, 2011
    Report Date
    June 10, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE FRACTURE SURFACE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. THE GIVEN INFORMATION INDICATES THAT THE REAMER TIP MUST HAVE BEEN IN CONTACT WITH THE GUIDE WIRE AND BROKE OFF DUE TO AN OVERLOADING SITUATION DURING DRILLING. SUCH PROBLEMS CAN OCCUR IF THE GUIDE WIRE IS SLIGHTLY BENT WHAT COULD LEAD TO CONTACT. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE INVESTIGATION RESULTS CONCLUDED THAT THE REAMER TIP MUST HAVE BEEN IN CONTACT WITH THE GUIDE WIRE AND BROKE OFF DUE TO AN OVERLOADING SITUATION DURING DRILLING. THUS, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOP IS BROKEN OFF AND THE FRAGMENT WAS REMOVED. THE DOCTOR USED THE REAMER WITH GUIDE WIRE AND SUDDENLY THE TIP OF THE REAMER WAS BROKEN. THE DOCTOR REMOVED THE FRAGMENT COMPLETELY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272487 REAMER Ø11 F/PFNA BLADE HTO SYNTHES GMBH SX403278

    Patients

    Seq Age Sex Outcome Treatment
    1