BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT QC/T15

    MDR report key: 11961839 · Received June 8, 2021

    Report

    Report Number
    8030965-2021-04697
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819816817
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. D9. H3, H6: PART: 03.400.101. LOT: 9031950. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: 12 SEP 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE PRODUCT WAS RETURNED TO US CUSTOMER QUALITY (CQ) FOR EVALUATION. THE US CQ TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SCRDRIVERSHAFT-2.5-HEX T15 THE DEVICE WAS RECEIVED AFTER DECONTAMINATION, NO ISSUES WERE OBSERVED BUT BASED ON THE PHOTOS PROVIDED IN THE LOCAL LETTER BY JAPAN TEAM, WE WILL BE CONFIRMING THE COMPLAINT CONDITION AND NO OTHER ISSUES WERE IDENTIFIED. THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO ALLEGED COMPLAINT CONDITION. THE OBSERVED CONDITION OF SCRDRIVERSHAFT-2.5-HEX T15 THE DEVICE WAS CONSISTENT. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR SCRDRIVERSHAFT-2.5-HEX T15.THE STAIN WAS BECAUSE OF THE PHENOLIC HANDLE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. 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. DRAWING/SPECIFICATIONS REVIEWED? THE FOLLOWING DRAWING REFLECTING THE CURRENT AND MANUFACTURE REVISION WAS REVIEWED: SCREW DRIVER SHAFT 2.5 , HEXAGONAL,T15. 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 EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J SALES REPRESENTATIVE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE PATIENT UNDERWENT REMOVAL SURGERY. JUST BEFORE THE PROCEDURE, WHILE THE PRODUCTS IN QUESTION WERE STERILIZED, IT WAS FOUND THAT STAINS APPEARED INSIDE THE PACKAGES OF THE PRODUCTS. SURGEON USED OTHER SCREWDRIVER IN THE SURGERY INSTEAD OF THE PRODUCTS ARRANGED FOR. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT QC/T15. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855054 STARDRIVE SCREWDRIVER SHAFT QC/T15 SCREWDRIVER HXX SYNTHES GMBH 9031950 07611819816817

    Patients

    Seq Age Sex Outcome Treatment
    1 HAND F/SCRDRIVERSHAFT-2.5-HEX T15| HANDLE W/QUICK-COUPL| SCRDRIVERSHAFT-2.5-HEX T15| HAND F/SCRDRIVERSHAFT-2.5-HEX T15| HANDLE W/QUICK-COUPL| SCRDRIVERSHAFT-2.5-HEX T15