BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 3031826 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-10662
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. MANUFACTURING EVALUATION REPORTS THAT THE SAMPLE WAS RECEIVED WITH THE FRONT OF THE REAMER HEAD COMPLETELY BROKEN OFF. MICROSCOPIC VIEW OF THE FRACTURED SURFACES DID NOT SHOW ANY ANOMALIES OF MATERIAL STRUCTURE. THE MANUFACTURING DOCUMENTS SHOW THAT THE REAMER HEAD WAS PRODUCED ACCORDING TO THE SPECIFICATIONS. DUE TO DAMAGE, RELEVANT DIMENSIONS COULD NOT BE VERIFIED. PRODUCT DEVELOPMENT EVALUATION REPORTS THAT THE REAMER HEAD IS BROKEN IN 4 PIECES, A BASE AND 3 TIP PIECES. THERE ARE MINIMAL SIGNS OF RUST OR AGE. THE ROOT CAUSE DESIGN RELATED OR SURGICAL TECHNIQUE RELATED IS NOT DETERMINED. THEREFORE THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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. ORIGINAL AWARENESS DATE IS (B)(6) 2012, NEW INFORMATION WAS RECEIVED ON (B)(4) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERBODY FUSION (ORIF) TIBIA PROCEDURE WHILE THE SURGEON WAS REAMING THE CANAL, THE TIP OF THE MEDULLARY REAMER HEAD BROKE INTO FOUR PIECES. SURGEON USED ANOTHER REAMER HEAD TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS AND NO ADVERSE EFFECT TO PATIENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134463 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES GMBH 18684

    Patients

    Seq Age Sex Outcome Treatment
    1