BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 8524365 · Received April 17, 2019

    Report

    Report Number
    2939274-2019-57530
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    March 25, 2019
    Report Date
    March 25, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982196019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. H10: ADDITIONAL NARRATIVE: H3, H4, H6: PART 357.366, LOT 8893466: MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: JUNE 27, 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED IDENTIFIED MINOR SUPERFICIAL SURFACE WEAR BUT NO DAMAGE THAT WOULD INHIBIT FUNCTIONALITY WAS OBSERVED. THE LOCKING SLIDE PLATE TRANSLATED AS INTENDED. FURTHER FUNCTIONAL TESTING RELEVANT TO THIS COMPLAINT WAS NOT POSSIBLE BECAUSE THE BLADE GUIDE SLEEVE WAS NOT RETURNED. DIMENSIONAL INSPECTION INDICATED THE RELEVANT DIMENSIONS WERE WITHIN SPECIFICATION. THE RELEVANT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION; NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION OF THE RETURNED DEVICE, DEVICE HISTORY RECORD (DHR) REVIEW OF THE PART WITH GIVEN LOT NUMBER, DOCUMENT/ SPECIFICATION REVIEW WERE PERFORMED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED CONDITION COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THIS COMPLAINT WAS NOT ABLE TO BE CONFIRMED OR REPLICATED AND NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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. 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 · 0

    ADDITIONAL CONCOMITANT DEVICE: GUIDE SLEEVE (PART/LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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) 2019, DURING A HIP SURGERY, THE MECHANISM OF THE AIMING ARM FOR TROCHANTERIC FIXATION NAIL CAME POPPING OUT DURING A PROCEDURE INVOLVING A FEMORAL NAIL. THE COMPRESSION NUT WAS NOT STAYING ENGAGED WITH THE AIMING ARM AS THE SLEEVE WAS ADVANCED TO THE FEMUR. THERE WAS NOTHING WRONG WITH THE NAIL. THE BUTTRESS NUT JUST KEPT DISENGAGING THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN FEMORAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315655 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 357.366 8893466 10886982196019

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - GUIDES/SLEEVES/AIMING: SLEEVE| UNK - NAILS: FEMORAL