BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM

    MDR report key: 17191301 · Received June 23, 2023

    Report

    Report Number
    8030965-2023-07972
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 25, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819268845
    PMA / PMN Number
    K000682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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: D9: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY (LOT) A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT CODE#:413.338S LOT #:417P021 IT WAS ELECTRONICALLY REVIEWED AND NO NONCONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON: 06/10/2021 MANUFACTURING SITE:JABIL GRENCHEN EXPIRY DATE:01/09/2031 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 · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT AN EXTRACTION SURGERY FOR THE ORIF SURGERY FOR PROXIMAL TIBIA FRACTURE WITH LCP PLATE AND TI LOCKING SCREWS WHICH WAS PERFORMED ON (B)(6)2022. DURING REMOVAL OF THE SCREWS IN THE PROXIMAL TIBIA, THE SCREWS WERE NOT TURNED AT ALL AND COULD NOT BE EXTRACTED, SO A CARBIDE DRILL WAS USED TO REMOVE THE SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM. THIS IS REPORT 4 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854649 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH 417P021 07611819268845

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LCP-PLT 4.5/5.0 LE 5HO L140 TAN| LOCKSCR Ø5 SELF-TAP L32 TAN| LOCKSCR Ø5 SELF-TAP L34 TAN| LOCKSCR Ø5 SELF-TAP L55 TAN| LOCKSCR Ø5 SELF-TAP L65 TAN| LOCKSCR Ø5 SELF-TAP L70 TAN| LOCKSCR Ø5 SELF-TAP L80 TAN| UNK - DRILL BITS: TRAUMA