BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6807841 · Received August 21, 2017

    Report

    Report Number
    1719045-2017-10811
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Report Date
    July 28, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    UDI-DI
    10886982196262
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT REPORTED. DATE OF DEVICE BREAKAGE IS NOT KNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW FOR PART #357.403, SYNTHES LOT#UP51710. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 08-DEC-2005, 09-DEC-2005. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE ALREADY HAS A BROKEN TIP. THE 357.403 6.0MM/10.0MM STEPPED CANNULATED DRILL BIT IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM. IT IS INTENDED FOR USE IN DENSE BONE TO PREPARE A PATH FOR THE FULL LENGTH OF THE HEAD ELEMENT DURING TFN PROCEDURES. THE DEVICE WAS RETURNED AND IT WAS REPORTED THAT "THE TIP OF A 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE WITH QUICK COUPLING WAS FOUND BROKEN OFF " THIS CONDITION IS CONFIRMED; THE INSTRUMENT WAS RETURNED WITH AN APPROXIMATELY 7.7 MM X 5.7 MM (L X H) FRAGMENT OF THE DISTAL TIP MISSING. THE FRAGMENT(S) WAS NOT RETURNED AND THE LOCATION OF THE FRAGMENT(S) IS UNKNOWN. THE BALANCE OF THE RETURNED DEVICE IS IN FAIR CONDITION, THERE IS NO DISCOLORATION, BUT THE EDGES OF THE HELIX BLADE ARE SLIGHTLY BURRED. DHR REVIEW FOR PART #357.403, SYNTHES LOT#UP51710 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DRAWING (MFG TO CURRENT) WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. A DCRM REVIEW AND/OR OCCURRENCE RATE CALCULATION MUST BE PERFORMED FOR ALL COMPLAINT PARTS WHICH RESULTED IN A CLASSIFICATION OF SERIOUS INJURY THAT WERE NOT GENERATED FROM A LITERATURE ARTICLE. THEREFORE, NO DCRM CALCULATION WILL BE PERFORMED FOR THIS COMPLAINT. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO EXCESSIVE FORCE APPLIED TO THE TIP OF THE DEVICE (I.E. FROM DENSE BONE) AND/OR CONSISTENT USE AND CUMULATIVE WEAR OVER THE PART'S LIFETIME (11+ YEARS) CAUSING MATERIAL FATIGUE AND BREAKAGE. 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 THE TIP OF A 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE WITH QUICK COUPLING WAS FOUND BROKEN OFF IN CENTRAL STERILE PROCESSING. NO KNOWN PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587908 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM REAMER HTO SYNTHES MONUMENT UP51710 10886982196262

    Patients

    Seq Age Sex Outcome Treatment
    1