BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE

    MDR report key: 7726842 · Received July 27, 2018

    Report

    Report Number
    8030965-2018-55323
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Date of Event
    July 9, 2018
    Report Date
    July 11, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819980662
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 04.210.118S, LOT: L920656: MANUFACTURING SITE: SELZACH, SUPPLIER: FRUEH VERPACKUNGSTECHNIK AG, RELEASE TO WAREHOUSE DATE: 05. JUNE 2018, EXPIRY DATE: 01. MAY 2028: PART WAS ONLY PACKED AND STERILIZED AT SYNTHES GMBH AND AS THIS COMPLAINT IS NEITHER PACKAGING NOR STERILIZATION RELATED NO REVIEW OF THESE DOCUMENTS IS NECESSARY. PLEASE PERFORM AN US DHR REVIEW FOR UNSTERILE PART 04.210.118 WITH LOT H558588. PART NUMBER: 04.210.118, LOT #: H558588 (NON-STERILE) - 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM: LOT QUANTITY: (B)(4), MANUFACTURING LOCATION: MARK TWO ENGINEERING / PACKAGED BY MONUMENT, RELEASE TO WAREHOUSE DATE: 14-MAR-2018: WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE SUPPLIED BY MARK TWO ENGINEERING DATED 08-MAR-2018 WAS REVIEWED AND FOUND TO BE CONFORMING. INSPECTION SHEET, INCOMING FINAL INSPECTION MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) LMD REV AC WAS REVIEWED AND FOUND TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING INSPECTION OR RELEASE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE VA LOCKING SCREW WAS NOT RETURNED FOR EVALUATION, THEREFORE NO ABSOLUTE CONCLUSION IS POSSIBLE. HOWEVER, BASED ON THE INVESTIGATION RESULT WITH THE STRONGLY DAMAGED LOCKING THREAD AT THAT SCREW IT CAN BE STRONGLY ASSUMED THAT THE LOCKING THREAD OF THE PLATE WAS ALSO DAMAGED AFTER THE INAPPROPRIATE INSERTION OF THE FIRST VA LOCKING SCREW. THEREFORE THE COMPLAINT IS CONFIRMED FOR THE SECOND SCREW AS FUNCTIONALITY OF THE LOCKING THREAD OF THE PLATE WAS MORE THAN LIKELY NOT ENSURED ANYMORE AFTER THE FIRST SCREW WAS INSERTED. 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 OR THE MATERIAL IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. OUTCOMES ATTRIBUTED TO ADVERSE EVENT: IT SHOULD BE NONE AS NO ADDITIONAL INTERVENTION REQUIRED DURING PROCEDURE. 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

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. UNKNOWN IF THE DEVICE WAS IMPLANTED OR NOT IMPLANTED DURING THE PROCEDURE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS SYNTHES SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH 2.4MM TI VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) TO TREAT THE DISTAL PART OF THE BONE HEAD. DURING THE SURGERY, THE VA LOCKING SCREW IN QUESTION COULD NOT BE LOCKED ON THE VA-LCP PLATE IN QUESTION. THE SURGEON TRIED TO INSERT THE SCREW FROM VARIOUS ANGLES, BUT THE SCREW COULD NOT BE LOCKED. THEN, ANOTHER NEW SCREW WAS USED, HOWEVER, IT ALSO COULD NOT BE LOCKED. THE PLATE COULD NOT BE RETURNED SINCE IT IS STILL IMPLANTED IN THE PATIENT. THE SURGERY WAS COMPLETED WITH A 30-MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH PATIENT OUTCOME REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567486 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L920656 07611819980662

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention