BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX

    MDR report key: 9110345 · Received September 24, 2019

    Report

    Report Number
    2939274-2019-60839
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    August 26, 2019
    Report Date
    August 26, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982068095
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (P/N 03.010.227 LOT 1962611) WAS RECEIVED WITH ONE OF THE KNOB LOCKING CAMS (03.010.048.12) AND ITS RETURN SPRING (03.010.048.3) FALLEN OFF OF THE AIMING ARM. THE DOWEL PIN, WHICH ASSEMBLES THE KNOB ONTO THE CAM LOCK WAS MISSING, CAUSING THE KNOB AND ITS RETURN SPRING TO FALL OFF. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWINGS, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (P/N 03.010.227 LOT 1962611) AS ONE OF THE KNOB LOCKING CAMS (03.010.048.12) AND ITS RETURN SPRING (03.010.048.3) FELL OFF OF THE AIMING ARM DUE TO A MISSING DOWEL PIN. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED FOR THE MISSING DOWEL PIN. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.010.227. LOT: 1962611. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: 22. OCTOBER 2008. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    MAUDE MW5089465 WAS RECEIVED FROM FDA ON SEPTEMBER 17, 2019. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON (B)(6) 2019, AN AIMING ARM FOR ADOLESCENT LATERAL FEMORAL NAIL (LFN) ENTRY BROKE. THE DEVICE HAS FOUR GOLD LOCKING MECHANISMS THAT HOLD TWO PROTECTION SLEEVES FOR THE INSERTION OF LFN RECONSTRUCTION LOCKING SCREWS. ONE OF THE GOLD LOCKING MECHANISMS POPPED OFF THE AIMING ARM AND WAS UNABLE TO BE REPLACED. THE PROCEDURE WAS COMPLETED USING ONLY 3 OF THE 4 LOCKING MECHANISMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES: PROTECTION SLEEVES (PART: 03.010.075, LOT: UNKNOWN, QUANTITY: 2), LFN RECONSTRUCTION LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR AN AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906313 AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.227 1962611 10886982068095

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING| 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING| UNK - LFN RECONSTRUCTION LOCKING SCREWS