BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    MDR report key: 7452558 · Received April 23, 2018

    Report

    Report Number
    2939274-2018-51871
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    March 29, 2018
    Report Date
    April 3, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982081612
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH 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. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE WAS WHEN PATIENT WAS IMPLANTED WITH ONE (1) RECON-NAIL AND TWO (2) RECON-SCREWS DURING A HIP SURGERY ON (B)(6) 2018. ALERT DATE CHANGED TO REFLECT UPDATE RECEIVED FROM SC. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ADDITIONAL 510K CODE: K040336. (B)(4) USED FOR: THE SCREW WAS FOUND TO BE TOO LONG POSTOPERATIVELY ON X-RAY BUT DID NOT PENETRATE. THE SURGEON TOOK THE PATIENT BACK INTO SURGERY WHERE THE SCREW WERE BACKED OUT A SMALL AMOUNT. 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. 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

    T WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ONE (1) RECON-NAIL AND TWO (2) RECON-SCREWS DURING A HIP SURGERY ON (B)(6) 2018. IT WAS NOTICED WITH THE HELP OF POST-OPERATIVE X-RAYS, THAT THE RECON SCREWS SEEMED TOO LONG, SO THE SURGEON BROUGHT THE PATIENT BACK TO THE SURGERY ON (B)(6) 2018 TO BACK THE SCREWS OUT A COUPLE OF TURNS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT STATUS WAS REPORTED TO BE FINE AT THE END OF THE PROCEDURE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293344 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.003.029 10886982081612

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention