BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    MDR report key: 5676338 · Received May 24, 2016

    Report

    Report Number
    1719045-2016-10432
    Event Type
    Malfunction
    Date Received
    May 24, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 10, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE 6.0MM/10.0MM STEPPED CANNULATED DRILL BIT (PART 357.403 / LOT NUMBER U141071) WAS RETURNED AND REPORTED TO HAVE BROKEN AT THE TIP DURING SURGERY. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY WEAR AND DULLNESS FROM OVER FOUR YEARS OF CONSISTENT USE; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. THE DRILL BIT IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM. THE REPORTED CONDITION IS CONFIRMED AS THE MOST DISTAL STEP OF THE DRILL BIT HAS ENTIRELY SHEARED OFF AT A SLIGHT ANGLE. IT IS LIKELY THAT WEAR AND DULLNESS FROM OVER FOUR YEARS OF CONSISTENT USE HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN OCTOBER, 2011 AND IS OVER FOUR YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH MARKINGS AND OTHER SIGNS OF WEAR ALONG ITS LENGTH. THE DRAWING NUMBER WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT ID NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW PART NUMBER: 357.403, SYNTHES LOT NUMBER: U141071, RELEASE TO WAREHOUSE DATE: 19-OCT-2011, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 AN INITIAL SURGERY OF A METASTATIC FEMUR FRACTURE (B)(6) 2016, THE DRILL TIP BIT BROKE WHILE REAMING THE VERY HARD FEMORAL NECK BONE. THE FRAGMENTS WERE RETRIEVED. A TWO MINUTE SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFUL AND PATIENT OUTCOME REPORTED AS FINE. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329946 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM REAMER HTO SYNTHES MONUMENT U141071

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR