BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER GUIDE

    MDR report key: 10123145 · Received June 5, 2020

    Report

    Report Number
    2939274-2020-02682
    Event Type
    Malfunction
    Date Received
    June 5, 2020
    Date of Event
    January 1, 2020
    Report Date
    May 26, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZY
    UDI-DI
    10886982068026
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H6: 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.

    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6 INVESTIGATION SUMMARY. VISUAL INSPECTION: THE HAMMER GUIDE (P/N (B)(6), LOT # 9875110) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION IT WAS NOTICED THAT THE HAMMER GUIDE WAS LODGED INTO THE CONICAL EXTRACTION BOLT AND IS UNABLE TO BE DISASSEMBLED. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE. FUNCTIONAL TEST: FUNCTIONAL TEST WAS PERFORMED ON THE RETURNED DEVICES AND THE HAMMER GUIDE COULD NOT BE REMOVE FROM THE CONICAL BOLT. THE COMPLAINT CAN BE REPLICATED WITH THE RETURNED DEVICES. DIMENSIONAL INSPECTION: DUE TO POST MANUFACTURING DAMAGE AND CONFIRMED JAMMED/ SEIZED ON THE DEVICE THE DIMENSIONAL INSPECTION WAS NOT PERFORMED. DOCUMENT/SPECIFICATION REVIEW: GUIDING ROD (CURRENT & MANUFACTURED) COMPLAINT CONFIRMED? YES. CONCLUSION: THIS COMPLAINT WAS CONFIRMED AS THE HAMMER GUIDE (P/N (B)(6), LOT # 9875110) WAS UNABLE TO BE DISASSEMBLED FROM CONICAL BOLT. NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY PART: 03.010.170. LOT: 9875110. MANUFACTURING SITE:(B)(6). RELEASE TO WAREHOUSE DATE: (B)(6) 2016. 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

    ADDITIONAL NARRATIVE: ONLY EVENT YEAR IS KNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 AN UNKNOWN DATE, TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) EXTRACTION BOLT/TREPHINE WAS ATTACHED TO A CONICAL EXTRACTION BOLT FOR TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FOR EXTRACTION. THE SLAP HAMMER GUIDE WAS ATTACHED TO THE EXTRACTION BOLT AND THE NAIL AND ALL REQUISITE HARDWARE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT INCIDENT. AFTER THE CASE, THE EXTRACTION BOLT/TREPHINE WAS UNABLE TO BE UN-COUPLED FROM THE SLAP HAMMER GUIDE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICES REPORTED: CONICAL EXTRACTION BOLT FOR TROCHANTERIC FIXATION NAILS (PART NUMBER 357.42, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) HAMMER GUIDE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586802 HAMMER GUIDE HAMMER,SURGICAL FZY WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.170 9875110 10886982068026

    Patients

    Seq Age Sex Outcome Treatment
    1 CONICAL EXTRACTION BOLT.| CONICAL EXTRACTION BOLT