BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM

    MDR report key: 12831771 · Received November 17, 2021

    Report

    Report Number
    8030965-2021-09587
    Event Type
    Injury
    Date Received
    November 17, 2021
    Report Date
    October 25, 2021
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    UDI-DI
    07611819268920
    PMA / PMN Number
    K023941
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. 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 PART: 413.360S, LOT: L150032, MANUFACTURING SITE: GRENCHEN, SUPPLIER: N/A, RELEASE TO WAREHOUSE DATE: 06 OCTOBER 2016, EXPIRATION DATE: 01 SEPTEMBER 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT 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

    PRODUCT COMPLAINT #: (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT HAD A SURGERY FOR OSTEOSYNTHESIS OF THE DISTAL FEMORAL FRACTURE WITH THE LCP-DF PLATE ON (B)(6) 2016. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY OF THE LCP-DF PLATE FOR THE TKA SURGERY. DURING THE REMOVAL SURGERY, THE SURGEON COULD NOT REMOVE THE FOUR DISTAL LOCKING SCREWS AND THE EXTRACTION SCREW GOT BROKEN IN THE SCREWHEAD. THE SURGEON SUCCEEDED IN REMOVING ALL IMPLANTS, BUT THE METAL POWDER GENERATED DURING EXCAVATION ADHERED TO THE SOFT PARTS BUT COULD NOT REMOVE THEM COMPLETELY. THE SURGERY WAS DELAYED BY 90 MINUTES AND COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM. THIS IS REPORT 3 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727626 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 60MM APPLIANCE,FIXATION,NAIL KTT WRIGHTS LANE : SYNTHES USA PRODUCTS LLC L150032 07611819268920

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention LCP-DF 4.5/5 R 5HO L156 TAN| LOCKSCR Ø5 SELF-TAP L28 TAN| LOCKSCR Ø5 SELF-TAP L32 TAN| LOCKSCR Ø5 SELF-TAP L40 TAN| LOCKSCR Ø5 SELF-TAP L44 TAN| LOCKSCR Ø5 SELF-TAP L65 TAN| LOCKSCR Ø5 SELF-TAP L70 TAN| LOCKSCR Ø5 SELF-TAP L70 TAN| LOCKSCR Ø5 SELF-TAP L75 TAN