BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN

    MDR report key: 7658081 · Received July 3, 2018

    Report

    Report Number
    2939274-2018-52693
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 8, 2018
    Report Date
    June 8, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982068590
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PART: 03.010.415; LOT: L202193; MANUFACTURING SITE: HAEGENDORF; RELEASE TO WAREHOUSE DATE: DECEMBER 05, 2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE FOLLOWING INVESTIGATIONS WERE PERFORMED: DEVICE INTERACTION/FUNCTIONAL: DEVICE CONDITION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED THE RETURNED CONNECTING SCREW TO BE SLIGHTLY BENT AT IS TRANSITION FROM SHAFT TO THREADED PORTION. NO NEW ISSUES WERE IDENTIFIED OTHER THAN OVER ALL WORN SURFACES ON THE RETURNED DEVICES WHICH WILL NOT AFFECT THE DEVICE FUNCTIONALITY. THE DEVICE WAS FUNCTIONALLY TESTED WITH THE RETURNED AIMING ARM GUIDE AND NO ISSUES SUCH AS STUCK CONDITIONS WERE OBSERVED. HOWEVER, FUNCTIONAL INSPECTION ON THE CONSTRUCT INCLUDING THE AIMING ARM AND REPLICATION OF COMPLAINT CONDITION WAS NOT ABLE TO BE PERFORMED AS THE MATING DEVICE (AIMING ARM) WAS NOT RECEIVED. HOWEVER, WITH THE DAMAGE IDENTIFIED, THE COMPLAINT CONDITION AGREE WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION WAS CONFIRMED. DRAWING REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. TOP LEVEL DRAWING, THREADED SHAFT DRAWING. DIMENSIONAL ANALYSIS AND DOCUMENT/SPECIFICATION REVIEW: DIMENSIONAL INSPECTION PERFORMED AT THE SHAFT MEASURED THE DIAMETER AS 3MM (CA-814) WHICH FALLS WITHIN THE SPECIFICATIONS OF 3MM +/- 0.1MM AND TOLERANCE SPECIFIED. 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. CONCLUSION: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE PROVIDED INFORMATION. HOWEVER, IT IS LIKELY THAT ANY UNINTENDED OFF-AXIS ALIGNMENT OF DEVICES DURING USAGE COULD HAVE CONTRIBUTED TO THIS COMPLAINT CONDITION. THE OVERALL COMPLAINT CONDITION IS CONFIRMED; HOWEVER, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. CORRECTED DATA: 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

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE GUIDE WIRE AIMING DEVICE FOR THE TROCHANTERIC FIXATION NAIL (TFN) AND TWO (2) CONNECTING SCREWS FOR GUIDE WIRE AIMING DEVICE WERE NOT INTERFACING CORRECTLY WITH 125 DEGREE AND 130 DEGREE AIMING ARMS. THE TOOLS WERE ABANDONED FROM USAGE. VISUAL TECHNIQUE WAS USED TO PROCEED WITH NAIL DEPTH ASSESSMENT. A USER ERROR WAS SUSPECTED AND FOLLOW-UP EQUIPMENT INSPECTION WAS NEEDED. THE CONNECTING SCREWS WERE FOUND BENT AND THE THREADS WERE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 2 MINUTES OF SURGICAL DELAY DUE TO SWAPPING OF THE SECOND CONNECTING SCREW. THE PATIENT WAS REPORTEDLY FINE AT THE END OF THE PROCEDURE. IN ADDITION, ON JUNE 11, 2018, A NON-STERILE INSPECTION WAS DONE WHICH VALIDATED THE CONFIRMATION OF A POOR INTERFACE. CONCOMITANT DEVICE/S REPORTED: 125 DEGREE AIMING ARM (PART: 03.037.014, LOT: UNKNOWN, QUANTITY: 1); 130 DEGREE AIMING ARM (PART: 03.037.013, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502634 CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC L202193 10886982068590

    Patients

    Seq Age Sex Outcome Treatment
    1 THERAPY DATE: (B)(6) 2018| THERAPY DATE: (B)(6) 2018