BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE

    MDR report key: 8907568 · Received August 19, 2019

    Report

    Report Number
    2939274-2019-59910
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Report Date
    July 22, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188809910
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE 1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE (P/N 314.411, LOT # 4051871) WAS RETURNED AND RECEIVED THE DEVICE WAS DISASSEMBLED ON RECEIPT. THE ETCHINGS WERE BEGINNING TO FADE. NO OTHER ISSUES COULD BE IDENTIFIED WITH THE RETURNED PORTIONS OF THE DEVICE. THE COMPLAINT WAS NOT CONFIRMED FOR THE 1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE (P/N 314.411, LOT # 4051871). THE SCREWDRIVER BLADE WAS RECEIVED DISASSEMBLED FROM THE HOLDING, EXTERNAL, AND INTERNAL SLEEVES, WHICH WERE FULLY ASSEMBLED. THE ETCHINGS ON THE EXTERNAL SLEEVE WERE BEGINNING TO FADE. NO OTHER DAMAGE COULD BE IDENTIFIED ON THE DEVICE. THE DEVICE WAS MOST LIKELY REPORTED AS FELL APART DUE TO NOT BEING REASSEMBLED FOLLOWING DISASSEMBLY FOR CLEANING. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. 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 LOT: PART #: 314.411 . SYNTHES LOT #: 4051871. MANUFACTURING LOCATION: BRANDYWINE. RELEASED TO WAREHOUSE DATE: 05JAN2000. NO NCRS WERE GENERATED DURING PRODUCTION. MANUFACTURING RECORD EVALUATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MANUFACTURING RECORD EVALUATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. 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. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE 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 ON AN UNKNOWN DATE, THE COMPONENTS OF THE CRUCIFORM SCREWDRIVER CANNOT BE ASSEMBLED. IT WAS DISCOVERED DURING AN INSPECTION IN THE STERILE PROCESSING DEPARTMENT WHEN THE SET WAS BEING ASSEMBLED FOR STERILIZATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699290 1.3MM SCREWDRIVER BLADE WITH HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.411.96 4051871 10886982188809910

    Patients

    Seq Age Sex Outcome Treatment
    1