BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5MM MEDULLARY REAMER HEAD

    MDR report key: 2972242 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-10288
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    December 25, 2011
    Report Date
    January 2, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH 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. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). PRODUCT WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THIS CASE IS INDETERMINATE FROM A DESIGN PERSPECTIVE DUE TO LACK OF INFORMATION AND INDICATIONS OF POSSIBLE OVER USE. THE MANUFACTURING DOCUMENTS SHOW THAT THE INSTRUMENT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS IN MAY 2004. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE PRODUCT DEVELOPMENT EVALUATION REVEALED THE REAMER HEAD WAS RECEIVED BROKEN AT THE BACK OF THE PART NEAR WHERE THE BORE WIDENS FOR A SHORT DISTANCE. THE FRONT CUTTING FLUTES APPEAR MODERATELY SHARP WITH A DIVOTS IN THE CUTTING SURFACES. THERE ARE ALSO SOME STRIATIONS RUNNING UP THE LENGTH OF THE PART IN BETWEEN THE CUTTING FLUTES. THERE WAS NO RUST ON THE PART. ALL MEASURABLE DIMENSIONS FALL WITHIN THE ALLOWABLE TOLERANCES. IT IS UNLIKELY THE DEVICE DESIGN CAUSED THE FAILURE IN THIS CASE. THE APPEARANCE OF THE CUTTING FLUTES INDICATES THAT THIS PART WAS FAIRLY USED. IT IS LIKELY THAT THIS BREAK WAS CAUSED BY THE USE OF A BLUNT INSTRUMENT. THE REAMING ROD AND FLEXIBLE SHAFT WERE NOT RETURNED SO IT IS IMPOSSIBLE TO COMMENT ON WHETHER THEY WERE BENT, BROKEN, OUT OF SPEC, ETC BECAUSE THE REAMER HEAD IS USED AS PART OF AN ASSEMBLY, IT WOULD BE HELPFUL TO EXAMINE ALL OF THE PARTS INVOLVED. USING THE REAMER HEAD OVER A BENT REAMING ROD OR WITH UNFIT FLEXIBLE SHAFT COULD HAVE ALSO CONTRIBUTED TO THE BREAK. THIS CASE IS INDETERMINATE FROM A DESIGN PERSPECTIVE DUE TO LACK OF INFORMATION AND INDICATIONS OF POSSIBLE OVER USE. THE MANUFACTURING EVALUATION REVEALED A PART OF THE REAMER HEAD IS BROKEN OFF AT THE BACK/COUPLING. THE CUTTING BLADES/LOOK BLUNT; VISIBLE STRIATIONS RUNNING UP THE LENGTH OF THE PART IN THE GROOVES. THE CUTTING EDGES OF THE REAMER HEAD SHOW SEVERAL MARKS AND ARE BLUNT. ALL MEASURABLE DIMENSIONS FALL WITHIN THE ALLOWABLE TOLERANCES. THE MICROSCOPIC VIEWS OF THE FRACTURED SURFACES DO NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. THE MANUFACTURING DOCUMENTS SHOW THAT THE INSTRUMENT WAS PRODUCED ACCORDING TO THE SPECIFICATIONS IN (B)(4) 2004. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTRAMEDULLARY NAIL OF TIBIA PROCEDURE, THE REAMER HEAD ((B)(4)) BROKE. THE BROKEN PIECE WAS RETRIEVED.

    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
    76877 8.5MM MEDULLARY REAMER HEAD HTO SYNTHES GMBH 2090334

    Patients

    Seq Age Sex Outcome Treatment
    1