BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LOCKING DRILL GUIDE

    MDR report key: 5410916 · Received February 4, 2016

    Report

    Report Number
    9680938-2016-10016
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Report Date
    January 20, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: ONE (1) SINGLE LOCKING DRILL GUIDE (PART 387.286, LOT A70A08, MANUFACTURED MARCH 2005) WAS RETURNED WITH A COMPLAINT STATING THAT THE TIP WAS DISCOVERED BROKEN DURING A FIELD EQUIPMENT INSPECTION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT ONE OF THE FLANGES OF BUSHING WAS BROKEN. THE COMPLAINT IS CONFIRMED. PER THE TECHNIQUE GUIDE, THE SINGLE LOCKING DRILL GUIDE (PART 387.286) IS PART OF THE CERVICAL SPINE LOCKING PLATE (CSLP) VARIABLE ANGLE (VA) SYSTEM THAT IS INDICATED FOR INTERNAL ANTERIOR FIXATION OF THE SPINE (C2-T2) FOR THE MANAGEMENT OF FRACTURES, DEGENERATIVE DISORDERS. THE SINGLE LOCKING DRILL GUIDE IS USED FOR THE INSERTION OF FIXED OR VARIABLE ANGLE BICORTICAL SCREWS INTO CSL PLATES. THE RELEVANT PRODUCT DRAWING WAS REVIEWED DURING THE INVESTIGATION. THE DESIGN AND MATERIALS WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. ONE OF THE FLANGES HAS BROKEN OFF AT THE SHOULDER. THERE COULD BE SEVERAL FACTORS CONTRIBUTING TO THE INCIDENT. THIS DEVICE WAS MADE 11 YEARS AGO, AND OVER THE YEARS MOST LIKELY ACCUMULATED STRESSES LEADING IT TO FATIGUE AND BREAK. ALSO, IF EXCESSIVE SIDE LOAD IS IMPARTED ON THE DEVICE, A CANTILEVER FORCE COULD CAUSE A BREAKAGE. THIS COULD HAPPEN IF THE INSTRUMENT IS BEING USED TO MANIPULATE THE PLATE INSIDE THE WOUND. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: PART NO. 387.286, SERIAL /LOT NO:A7OA08/ 4964240: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS MARCH 14, 2005. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. 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

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE DRILL GUIDE TIP WAS BROKEN. THE REPAIR TECHNICIAN REPORTED TIP BROKEN AS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. 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 INSPECTION ON (B)(6) 2016, THE SINGLE LOCKING DRILL GUIDE TIP WAS NOTICED BROKEN. ONE OF THE HINGES ON THE TIP OF THE DRILL GUIDE IS BROKEN OFF AND CANNOT BE LOCATED. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68931 SINGLE LOCKING DRILL GUIDE GUIDE FZX SYNTHES TUTTLINGEN 4964240

    Patients

    Seq Age Sex Outcome Treatment
    1