BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 6337804 · Received February 16, 2017

    Report

    Report Number
    9612488-2017-10058
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    January 24, 2017
    Report Date
    January 24, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    UDI-DI
    10886982194114
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 31. MAR. 2004. NONCONFORMANCES WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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. ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS PERFORMED. ONE 5.0MM FLEXIBLE SHAFT (PART NUMBER 352.040 / LOT NUMBER 2090792) WAS RECEIVED WITH THE COMPLAINT CATEGORY OF ¿BROKEN: INTRAOPERATIVELY.¿ IT WAS REPORTED THAT THE 5.0MM FLEXIBLE SHAFT BROKE IN HALF DURING INSERTION. THE SURGEON REMOVED THE BROKEN SHAFT EASILY USING VICE GRIPS. THE SURGERY WAS DELAYED BY LESS THAN TEN (10) MINUTES. THE COMPLAINT CONDITION IS CONFIRMED AS THE FLEXIBLE SHAFT WAS RECEIVED WITH THE PROXIMAL PORTION BROKEN OFF. WITH THE FRACTURE SURFACES ALIGNED IT WAS NOTED THAT NOT ALL PIECES WERE RETURNED. THE BALANCE OF THE DEVICE SHOWS WEAR CONSISTENT WITH SUBSTANTIAL USE OVER THE DEVICES APPROXIMATE LIFESPAN OF 12.75 YEARS. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE ISSUE ARE UNKNOWN. THE ROUGHLY SPIRAL BREAK OF THE PROXIMAL SHAFT IS CONSISTENT WITH ACCUMULATED EXPOSURE (FATIGUE) AND/OR A SINGLE HIGH FORCE EXPOSURE WHICH EXCEEDED THE YIELD STRENGTH. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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 TFN-ADVANCED¿ PROXIMAL FEMORAL NAILING SYSTEM (TFNA) CASE ON (B)(6) 2017, THE 5.0MM FLEXIBLE SHAFT BROKE IN HALF DURING INSERTION. THE SURGEON REMOVED THE BROKEN SHAFT EASILY USING VICE GRIPS. THE SURGERY WAS DELAYED BY LESS THAN TEN (10) MINUTES. THERE WAS NO REPORTED PATIENT HARM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE PROCEDURE, THE STERILE PROCESSING DEPARTMENT REPORTED THAT THE SECOND FLEXIBLE REAMER SHAFT BROKE AT THE TIP (CAPTURED IN (B)(4)). CONCOMITANT DEVICES REPORTED: SYNTHES SMALL BATTERY DRIVE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), REAMER QUICK CONNECT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118886 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES BETTLACH 2090792 10886982194114

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 1 QTY OF UNKNOWN REAMER QUICK CONNECT| 1 QTY OF UNKNOWN SYNTHES SMALL BATTERY DRIVE