BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM

    MDR report key: 10344730 · Received July 30, 2020

    Report

    Report Number
    8030965-2020-05468
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    July 9, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    PMA / PMN Number
    K131186
    Removal / Correction Number
    Z-0879-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: A PRODUCT INVESTIGATION WAS CONDUCTED. 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. 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: (6L28349) WAS MANUFACTURED IN OCT. 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) AND PART OF THE FIELD SAFETY NOTICE FSN. 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 AND HENCE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 02.200.014TS, LOT NUMBER: 6L28349, MANUFACTURING SITE: SELZACH, SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG, RELEASE TO WAREHOUSE DATE: 14. OCT. 2019, EXPIRY DATE: 01. SEP. 2024. LOT: 6L28349 IS PART OF CAPA, 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 · 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: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, SEVEN (7) SCREWS DID NOT COME OUT OF THE STERILE TUBE. THE PROCEDURE WAS COMPLETED BY USING OTHER UNKNOWN SCREWS. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS: CORTEX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM (PART# 02.200.014TS, LOT# 6L28349, QUANTITY# 1), 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE 16MM STERILE (PART# 201.766TS, LOT# 6L34625, QUANTITY# 1), 2.4MM VA LOCKING SCREW STARDRIVE 12MM STERILE (PART# 02.210.112TS, LOT# 6L35133, , QUANTITY# 3), 2.4MM VA LOCKING SCREW STARDRIVE 16MM STERILE (PART# 02.210.116TS, LOT# 6L35430, QUANTITY# 4). THIS REPORT IS FOR ONE (1) UNK - SCREWS: CORTEX. THIS IS REPORT 10 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 16 DEVICES REPORTED IN THIS COMPLAINT. (B)(4) CAPTURES THE OTHER 6 OUT OF 16 DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812337 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 6L28349

    Patients

    Seq Age Sex Outcome Treatment
    1 CORTSCR A| CORTSCR Ø2.4 SELF-TAP L16 SST| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| CORTSCR A| CORTSCR Ø2.4 SELF-TAP L16 SST| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE| VA LOCKING SCREW STARDRIVE® Ø 2.4 MM, SE