BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 26MM

    MDR report key: 10343981 · Received July 30, 2020

    Report

    Report Number
    8030965-2020-05443
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    July 9, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    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. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY: A CORTEX SCREW WITHIN ITS STERILE TUBE WAS RETURNED FOR INVESTIGATION WITH THE REPORTED CONDITION THAT THE SCREW TUBE DID NOT DEPLOY FROM OUTER TUBE IN THEATRE. THIS PRODUCTION LOT (4L05894) IS NOT PART OF CAPA - HOWEVER, THIS OCCURRENCE WAS PREVIOUSLY INVESTIGATED WITH THE FOLLOWING OUTCOME: FINAL CONCLUSION BY CUSTOMER QUALITY /PACKAGING PDC: AS PART OF THE COMPLAINT INVESTIGATION RELATED TO TUBES UNABLE TO DISASSEMBLE / SCREW COULD NOT BE REMOVED / PACKAGE COULD NOT BE OPENED / INNER TUBE WAS STUCK IN OUTER TUBE / INNER PART WITH THE SCREW OF THE STERILE TUBE GOT STUCK IN THE OUTER PART / INNER TUBE DID NO DEPLOY FROM OUTER TUBE (FAILURE MODES), PARTS WERE RETURNED AND INSPECTED BY SYNTHES GMBH. UPON EVALUATION SYNTHES GMBH DETERMINED THE COMPLAINTS WERE LIKELY DUE TO AN ASSEMBLY ERROR AT PACKAGING SUPPLIER (B)(4). THE EVALUATION REQUIRED OPENING AND CLOSING THE TUBES, WHICH MADE FURTHER EVALUATION BY (B)(4) IMPOSSIBLE, THEREFORE (B)(4) PERFORMED A PRODUCTION REVIEW WHERE THEY STATED THAT NO ASSEMBLY ERROR OCCURRED. IT IS THE POSITION OF SYNTHES GMBH THAT THE COMPLAINT IS ATTRIBUTED TO THE ASSEMBLY PROCESS AT (B)(4). HOWEVER, AS PART OF AN UNRELATED PRODUCT ISSUE (B)(4) INCORPORATED ADDITIONAL 100% MANUFACTURING CONTROLS (I.E. TORQUE LIMITERS) FOLLOWED BY 100% IN-PROCESS INSPECTION (I.E. GAUGES) TO ENSURE THE PRODUCTS WOULD BE ASSEMBLED CORRECTLY. THESE ADDITIONAL STEPS WERE DETERMINED TO BE SUFFICIENT FOR (B)(4) AND SYNTHES GMBH TO ELIMINATE THE ISSUES THAT LED TO PRODUCT COMPLAINTS RELATED TO UNABLE TO DISASSEMBLE / SCREW COULD NOT BE REMOVED / PACKAGE COULD NOT BE OPENED / INNER TUBE WAS STUCK IN OUTER TUBE / INNER PART WITH THE SCREW OF THE STERILE TUBE GOT STUCK IN THE OUTER PART / INNER TUBE DID NO DEPLOY FROM OUTER TUBE. IN CONCLUSION, THE MANUFACTURING CONTROLS AND IN-PROCESS INSPECTION WERE INTRODUCED ON 30TH JANUARY 2020 AND THEREFORE ANY COMPLAINTS RELATED THE FAILURE MODES MENTIONED ABOVE FOR PRODUCT MANUFACTURED PRIOR TO 30TH JANUARY 2020 WOULD NO LONGER OCCUR. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT: PART NUMBER: 02.200.026TS, SYNTHES LOT NUMBER: 4L05894, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: APRIL 04, 2019, EXPIRY DATE: MARCH 01, 2024, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 THE SCREW WOULD NOT DISENGAGED FROM THE TUBE. IT IS UNKNOWN WHEN THE EVENT OCCURRED AND IF THERE WAS PATIENT OR PROCEDURAL INVOLVEMENT. THIS IS REPORT 4 OF 8 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811071 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 26MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 4L05894

    Patients

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