BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM

    MDR report key: 3021477 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10464
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    October 30, 2011
    Report Date
    October 30, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION REVEALED THAT THE FLEXIBLE MEDULLARY REAMER WAS RECEIVED WITH THE WELDING BETWEEN THE FLEXIBLE SHAFT AND THE REAMER BROKEN DUE TO AN UNKNOWN CAUSE. THE SHAFT EXHIBITS NUMEROUS SCRATCHES ALONG THE SHAFT AND THE REAMER HAS MARKS ON THE CUTTING SURFACES. THE CERTIFICATE OF CONFORMITY INDICATED THE LOT WAS MADE TO THE CORRECT REQUIREMENTS AND SPECIFICATIONS. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. PRODUCT DEVELOPMENT EVALUATION WAS FLEXIBLE REAMER WAS RECEIVED WITH THE REAMER HEAD BROKEN OFF OF THE SHAFT. THE WELD THAT ATTACHES THE REAMER HEAD TO FLEXIBLE SHAFT APPEARS TO HAVE BROKEN, BECAUSE THE REAMER HEAD COMPONENT AND THE FLEXIBLE SHAFT COMPONENT ARE INTACT. THERE ARE MODERATE CIRCULAR STRIATIONS AROUND THE LENGTH OF THE FLEXIBLE SHAFT. THE REAMER HEAD HAS A FEW DIVOTS IN THE CUTTING SURFACES, BUT THERE IS NO RUST ON THE PART OR INDICATIONS OF OVERUSE. THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE BECAUSE THE PRODUCT DRAWING SPECIFIES THAT IT SHOULD BE ABLE TO WITHSTAND AN ADEQUATE AMOUNT OF TORSIONAL FORCE.

    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. REVIEW ALL TABS BEFORE SUBMITTING MEDWATCH FOR SIGNATURE/APPROVAL. ORIGINAL AWARENESS DATE IS 10/30/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR A HUMERUS FRACTURE, THE HEAD OF THE REAMER BROKE OFF INSIDE THE BONE. THE BROKEN PIECE WAS RETRIEVED AND THE CASE WAS COMPLETED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123113 8.0MM FLEXIBLE MEDULLARY REAMER/FLAT WIRE/385MM HTO SYNTHES MONUMENT 49926

    Patients

    Seq Age Sex Outcome Treatment
    1