BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    17.0MM CANNULATED DRILL BIT LARGE QC/300MM

    MDR report key: 7154614 · Received December 29, 2017

    Report

    Report Number
    2939274-2017-50491
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    December 2, 2017
    Report Date
    December 2, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTW
    UDI-DI
    10886982196194
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE AVAILABLE FOR EVALUATION: DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (DRILL BIT, PART NUMBER 357.394, LOT NUMBER UR68798). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THE COMPLAINT OF BROKEN WAS CONFIRMED. WHETHER THIS COMPLAINT COULD BE REPLICATED IS NOT APPLICABLE BECAUSE THE DEVICE WAS RETURNED BROKEN. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE DRILL BIT WAS BROKEN AT THE TRANSITION BETWEEN THE 8MM AND 6 MM DIAMETER SECTIONS. THE FRAGMENT WAS NOT RETURNED. DIMENSIONAL ANALYSIS WAS NOT PERFORMED AS RELEVANT FEATURES WERE NOT RETURNED. DRAWINGS WERE REVIEWED AND WERE DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DHR REVIEW SHOWED NO NCR¿S WERE GENERATED DURING PRODUCTION. MATERIAL AND HARDNESS TESTING WAS COMPLETED AT THE TIME OF MANUFACTURED AND CONFIRMED TO HAVE NO ISSUES THROUGH THE DHR REVIEW. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION, BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES (SUCH AS BEING STRUCK OFF AXIS). DEVICE HISTORY RECORD REVIEW. PART NUMBER: 357.394, SYNTHES LOT NUMBER: UR68798, RELEASE TO WAREHOUSE DATE: 19-MAR-2007, 28-MAR-2007, SUPPLIER: (B)(4). REVIEW OF THE DEVICE HISTORY RECORD 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.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW PENDING COMPLETION. 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 ON (B)(6) 2017, PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE. DURING THE PROCEDURE, THE OPENING DRILL BIT SNAPPED AT THE QUICK CONNECT ATTACHMENT. IT WAS CHUCKED ON A STRYKER SYSTEM 7 DRILL. DRILL BIT WAS REMOVED AND THE AWL WAS USED TO COMPLETE ENTRY. GENERATED FRAGMENTS WERE REMOVED EASILY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) 17.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933330 17.0MM CANNULATED DRILL BIT LARGE QC/300MM BIT,DRILL HTW WRIGHTS LANE SYNTHES USA PRODUCTS LLC UR68798 10886982196194

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR