BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE WITH MINI QUICK COUPLING

    MDR report key: 11349871 · Received February 19, 2021

    Report

    Report Number
    2939274-2021-00976
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Report Date
    January 29, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWX
    UDI-DI
    10886982187192
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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: PART NUMBER:311.01. SYNTHES LOT NUMBER: 5063122. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: AUGUST 19, 2005. EXPIRATION DATE: N/A. MANUFACTURED BY SYNTHES BRANDYWINE. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE HANDLE WITH MINI QUICK COUPLING (P/N: 311.01, LOT NUMBER: 5063122) WAS RECEIVED AT US CUSTOMER QUALITY CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO EXTERNAL DAMAGE. SERVICE AND REPAIR EVALUATION: IT WAS REPORTED THAT ON UNKNOWN DATE, THEY HAVE A SCREWDRIVER HANDLE THAT IS BROKEN. THE REPAIR TECHNICIAN REPORTED THE DEVICE WILL NOT COUPLE. COUPLER DAMAGED IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE AT MONUMENT S&R. THE DEVICE WAS UNABLE TO COUPLE. THE COMPLAINT WAS ABLE TO BE REPLICATED. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DEVICE IS UNABLE TO COUPLE AND IS FUNCTIONALLY BROKEN EVEN THOUGH THERE IS NO EXTERNAL DAMAGE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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 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. H3: THE DEVICE HAS BEEN 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 · 1

    PRODUCT COMPLAINT #: (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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 ON UNKNOWN DATE, THEY HAVE A SCREWDRIVER HANDLE THAT IS BROKEN. IT WAS UNKNOWN HOW IT OCCURRED. THERE WAS NO PROCEDURE AND PATIENT INVOLVED. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) HANDLE WITH MINI QUICK COUPLING. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245143 HANDLE WITH MINI QUICK COUPLING TAP,BONE HWX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 311.01 5063122 10886982187192

    Patients

    Seq Age Sex Outcome Treatment
    1