BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 4759734 · Received May 8, 2015

    Report

    Report Number
    2520274-2015-13720
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 19, 2015
    Report Date
    April 19, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: OCTOBER 26, 2005 NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: DURING AN INTRA-MEDULLARY NAILING (IM) RETROGRADE THE REAMER SHAFT (352.040 / LOT 2161495) ¿SNAPPED OUTSIDE THE BONE AND THE SURGEON WAS ABLE TO RETRIEVE THE SHAFT.¿ THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION OF ¿BROKEN¿ WAS ABLE TO BE CONFIRMED AS THE SHAFT HAD BROKEN APPROXIMATELY 60MM FROM THE PROXIMAL END OF THE INSTRUMENT. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, BASED ON THE COMPLAINT DESCRIPTION, THE FAILURE IS THE RESULT OF EXCESSIVE LOAD APPLIED TO THE DEVICE. THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION OF BROKEN WAS ABLE TO BE CONFIRMED AS THE SHAFT BROKE INTO TWO SEGMENTS APPROXIMATELY 60MM FROM THE PROXIMAL END OF THE DEVICE. THE SHAFT SHOWED EXPECTED WEAR FOR A TEN YEAR OLD INSTRUMENT AND THE DISTAL TIP APPEARED TO BE IN GOOD CONDITION WITH ALL FOUR PRONGS INTACT. THE SYSTEM¿S MEDULLARY REAMER HEADS RANGE IN SIZES FROM 8.5-19MM IN 0.5MM INCREMENTS. THE 8.5MM HEAD IS FRONT CUTTING; THE REMAINDER ARE SIDE CUTTING. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER THE FAILURE IS CONSISTENT WITH THE PROXIMAL SHAFT EXPERIENCING AN EXTREME AMOUNT OF TORQUE. DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE FLEXIBLE REAMER SHAFT SNAPPED OUTSIDE THE BONE AND THE SURGEON WAS ABLE TO RETRIEVE THE SHAFT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO HARM TO PATIENT USING ANOTHER REAMER SHAFT FROM ANOTHER SET WITH NO DELAY TO SURGERY. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303592 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES BETTLACH 2161495

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR