BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 3062316 · Received April 16, 2013

    Report

    Report Number
    1719045-2013-10661
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    September 13, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PRODUCT DEVELOPMENT EVALUATION REVEALS, THE DEVICE WAS RECEIVED. NO DESIGN ISSUES WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE COMPLAINT DESCRIPTION, THE DEVICES BROKE DURING INSERTION AND CONDITIONS OF THE PRODUCTS, IT IS POSSIBLE THAT THE DEVICE WAS NOT ASSEMBLED PROPERLY. HOWEVER, DUE TO A LACK OF INFORMATION ABOUT WHETHER OR NOT THE RIA WAS CORRECTLY ASSEMBLED DURING THE CASE, IT CANNOT BE CONCLUSIVELY DETERMINED WHAT THE CAUSE OF THE FAILURE WAS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. PLACEHOLDER.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON USED THE RIA TO COLLECT GRAFT FROM A PATIENT. WHEN INSERTING THE RIA ASSEMBLE, THE 13MM HEAD BROKE OFF AND THE TIP OF THE RIA DRIVE SHAFT BROKE AS WELL. BOTH DEVICES SPLIT INTO SEVERAL PIECES. THE PIECES OF THE RIA ASSEMBLY WERE ALL COLLECTED AND WENT INTO THE GRAFT. THE SURGEON PICKED OUT THE BROKEN PIECES OF THE ASSEMBLY AND CONTINUED ON WITH THE SURGERY. SEVERAL X-RAYS WERE TAKEN OF THE LEG TO ENSURE THAT THE PIECES WERE ALL COLLECTED. THERE WAS NO HARM TO THE PATIENT AND ALL OF THE PIECES WERE RETRIEVED. THIS IS 1 OF 2 REPORTS FOR EVENT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163393 13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR HTO SYNTHES MONUMENT 6408212

    Patients

    Seq Age Sex Outcome Treatment
    1