BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    17.0MM/3.2MM WIRE GUIDE 161MM

    MDR report key: 8976585 · Received September 9, 2019

    Report

    Report Number
    2939274-2019-60408
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Report Date
    July 25, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982196170
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. 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. CORRECTION: E1: REPORTER'S PHONE NUMBER AND EMAIL ADDRESS WERE INADVERTENTLY MISSED ON THE INITIAL REPORT AND HAVE BEEN UPDATED ACCORDINGLY. ADDITIONAL INFORMATION: H4: DEVICE MANUFACTURE DATE WAS INADVERTENTLY MISSED ON THE INITIAL REPORT AND HAS BEEN UPDATED ACCORDINGLY. THEREFORE, UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART: 357.392, LOT: 5871725, DATE OF MANUFACTURE: SEPTEMBER 11, 2008 ¿ OCTOBER 16, 2008. PLACE OF MANUFACTURE: DEPUY-SYNTHES (B)(4). PART EXPIRATION DATE: N/A, LIST OF NONCONFORMANCE'S: N/A. DEVICE HISTORY RECORD (DHR) REVIEW COMPLETED FOR THIS LOT; NO NONCONFORMANCE'S FOUND. THE DHR SHOWS THAT THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL, AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE 17.0 MM/3.2 MM WIRE GUIDE 161 MM WAS RECEIVED SHOWING THE EDGES ON THE DISTAL TIP BENT AND WARPED. THE EDGES OF THE DISTAL CANNULATION TIP ARE LIKELY MALFORMED FROM CONTINUOUS INSERTION INTO BONE OVER ITS LIFETIME (10+ YEARS). NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. THE RETURNED WIRE GUIDE DISPLAYED POTENTIAL END OF LIFE INDICATOR OF BENT / WARPED FEATURE FOR INSERTION / GUIDE INSTRUMENTS. CONCLUSION: AFTER A VISUAL INSPECTION PER GUIDANCE, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, A WIRE GUIDE WAS OBSERVED DAMAGED. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. UPON MANUFACTURER RECEIPT AND INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS BENT. THIS REPORT IS FOR A 17.0 MM/3.2 MM WIRE GUIDE 161 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767436 17.0MM/3.2MM WIRE GUIDE 161MM GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 357.392 5871725 10886982196170

    Patients

    Seq Age Sex Outcome Treatment
    1