BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 30MM

    MDR report key: 10367603 · Received August 5, 2020

    Report

    Report Number
    8030965-2020-05628
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Report Date
    July 15, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07612334176158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. VISUAL INSPECTION: THE CORTEX SCREW WAS RECEIVED WITH THE REPORTED CONDITION THAT THE INNER TUBE DID NOT DISENGAGE FROM OUTER TUBE. THE INSPECTION PERFORMED AT CQ ZUCHWIL CONFIRMED THAT AFTER UNSCREWING THE OUTER CAP THE ENTIRE INNER TUBE (CAP WITH HOLDER AND SCREW) IS RETAINED WITHIN THE OUTER TUBE, PREVENTING THE SCREW FROM BEING REMOVED AND USED. NO FURTHER DAMAGE IS VISIBLE. THE INSPECTION HAS ALSO SHOWN THAT THE DEVICE IS ETCHED WITH THE LOT 12L6709, PER NR-0133683 IS THIS THE SUB-COMPONENT LOT NUMBER OF PART 02.200M030, BASED ON THIS LOT IT WAS POSSIBLE TO IDENTIFY THE LOT NUMBER OF THE FINISHED UNSTERILE DEVICE 02.200.030 AS 17L0127. THIS UNSTERILE DEVICE WAS STERILIZED AND PACKED IN THE STERILE TUBE AFTERWARDS AND FINALLY SOLD UNDER THE PART NUMBER 02.200.030TS WITH LOT 6L42651. SUMMARY: THE COMPLAINT CONDITION IS CONFIRMED AS THE INNER TUBE IS RETAINED WITHIN THE OUTER TUBE DURING DISASSEMBLY PREVENTING THE SCREW FROM BEING REMOVED AND USED. THIS PRODUCTION LOT (6L42651) WAS MANUFACTURED IN NOVEMBER 2019 ACCORDING TO THE SPECIFICATION. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FURTHER INVESTIGATION HAS SHOWN THAT THIS PRODUCTION LOT IS PART OF THE CORRECTIVE AND PREVENTIVE ACTION (CAPA-009574) AND PART OF THE FIELD SAFETY NOTICE FSN 1655109. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CAPA EVALUATION (INADEQUATELY DEFINED DESIGN OF THE INNER TUBE & INNER CAP). ALL FURTHER INVESTIGATIONS AND ACTIONS WILL BE DOCUMENTED WITHIN CAPA-009574 AND HENCE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. DEVICE HISTORY PART: 02.200.030TS, LOT: 6L42651, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 18. NOV. 2019, EXPIRY DATE: 01. NOV. 2024. LOT 6L42651 IS PART OF CAPA-009574, THEREFORE NO INVESTIGATION IS REQUIRED FOR THIS LOT NUMBER AS THE INVESTIGATION INCLUDING ROOT CAUSE DEFINITION HAS ALREADY BEEN PERFORMED UNDER THIS CAPA. 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

    ADDITIONAL DEVICE PRODUCT CODES: HRS. DEVICE LOT NUMBER IS UNKNOWN. REPORTER IS A SYNTHES EMPLOYEE. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT FIVE (5) SCREWS IN TUBES WERE STUCK AND COULD NOT BE USED FOR THE PROCEDURE. THERE WAS NO REPORTED SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 30MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831452 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 30MM SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 6L42651 07612334176158

    Patients

    Seq Age Sex Outcome Treatment
    1