BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS

    MDR report key: 8684598 · Received June 10, 2019

    Report

    Report Number
    2939274-2019-58578
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Report Date
    May 14, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTD
    UDI-DI
    10886982072573
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. PART 03.111.751, LOT 516772: MANUFACTURING SITE: SELZACH. SUPPLIER: GSELL MEDICAL PLASTICS AG. RELEASE TO WAREHOUSE DATE: OCTOBER 18, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS COMPLETED BASED ON RETURNED PHOTOGRAPHS OF THE COMPLAINED DEVICE. PHOTOGRAPHS WERE RECEIVED SHOWING A PORTION OF THE CLAMP ATTACHMENT SITE/KNOB BROKEN OFF. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE IN THE IMAGES PROVIDED. DIMENSIONAL INSPECTION COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED. THE RELEVANT DRAWINGS WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE COMPLAINT CONDITION IS CONFIRMED AS IMAGES SHOWED A PORTION OF THE CLAMP ATTACHMENT SITE/KNOB BROKEN OFF. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES AND/OR ROUGH HANDLING. 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. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS SYNTHES SALES CONSULTANT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(6) 2019, DURING A ROUTINE MAINTENANCE, THE SOFT TISSUE ATTACHMENT, J-SHAPED, FOR REDUCTION FORCEPS WAS DISCOVERED BROKEN AT THE STERILE PROCESSING DEPARTMENT. THIS DID NOT OCCUR IN A CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SOFT TISSUE ATTACHMENT/J-SHAPED F/BONE REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477796 SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS FORCEPS HTD WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.111.751 516772 10886982072573

    Patients

    Seq Age Sex Outcome Treatment
    1