BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 44MM

    MDR report key: 12378869 · Received August 27, 2021

    Report

    Report Number
    8030965-2021-07295
    Event Type
    Injury
    Date Received
    August 27, 2021
    Report Date
    July 30, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    UDI-DI
    07611819231603
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. H3, H4, H6: PART: 414.844S LOT: L242164 MANUFACTURING SITE: (B)(6) SUPPLIER: (B)(6) RELEASE TO WAREHOUSE DATE: 28 DECEMBER 2016 EXPIRATION DATE: 01 DECEMBER 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE: PART: 414.844 LOT: L233594. 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 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

    ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE: HRS, HWC. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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 THAT, THE PATIENT UNDERWENT THE SURGERY FOR SUPRACONDYLAR FRACTURE OF THE LEFT FEMUR WITH THE PLATE, SCREW AND CABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON JULY 30, IT WAS FOUND THAT THE IMPLANTS WERE DISLOCATED AND THE PLATE WAS TOO SHORT, ENOUGH SCREWS WERE NOT INSERTED AT THE PROXIMAL BONE FRAGMENT. THE CABLE POSITION WAS NOT PROPER, AND CAUSED THE IMPLANT DISLOCATION. THE PATIENT CURRENTLY HAS A PROBLEM WITH THE FUNCTION OF THE LUNG, AND AFTER THE NUMERICAL VALUE HAS SETTLED DOWN, THE REVISION SURGERY WILL BE PERFORMED USING A LONGER PLATE. THIS REPORT IS FOR ONE (1) 4.5MM TI CORTEX SCREW SELF-TAPPING 44MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276331 4.5MM TI CORTEX SCREW SELF-TAPPING 44MM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES GMBH L242164 07611819231603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CERCL-CABLE W/CRIMP Ø1.7.| LCP-DF 4.5/5 LE 5HO L156 TAN.| CERCL-CABLE W/CRIMP Ø1.7| LCP-DF 4.5/5 LE 5HO L156 TAN