BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM

    MDR report key: 11150104 · Received January 11, 2021

    Report

    Report Number
    8030965-2021-00225
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 13, 2020
    Report Date
    December 15, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    UDI-DI
    07611819194441
    PMA / PMN Number
    K161616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6- THE RECEIVED PICTURE AND VIDEO WERE REVIEWED. BASED ON THE VIDEO IT CAN BE STATED THAT THE UNKNOWN GUIDE WIRE DOES PASS THROUGH THE SCREW BUT IT SEEMS TO BE VERY ROUGH-RUNNING. THEREFORE IS THE COMPLAINT RATED AS CONFIRMED. PRODUCT WAS NOT RETURNED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. 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 MATERIAL IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT PRODUCT CODE: 04.226.020. LOT NUMBER: 9810075. MANUFACTURING SITE: GRENCHEN. RELEASE TO WAREHOUSE DATE: 25. JAN. 2016. 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 · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS A HOSPITAL EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE WIRE DOES NOT PASS THROUGH THE SCREW. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS, TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 3.0MM TI HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45365 3.0MM TI HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM SCREW,FIXATION,BONE HWC SYNTHES GMBH 9810075 07611819194441

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: TRAUMA