BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX X20 TORQUE DRIVER SHAFT

    MDR report key: 11703598 · Received April 21, 2021

    Report

    Report Number
    1526439-2021-00761
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 25, 2021
    Report Date
    March 25, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034224428
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: UPDATED DATA: D4, H4. INVESTIGATION SUMMARY VISUAL INSPECTION: THE SFX X20 TORQUE DRIVER SHAFT (P/N: 289410300, LOT #:0209NT) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE TIP OF THE DEVICE WAS OBSERVED TO BE STRIPPED AND DEFORMED. ADDITIONALLY SCRATCHES WERE OBSERVED AS WELL FROM REGULAR FIELD USAGE. THE RECEIVED CONDITION OF THE DEVICES IS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICES. NO OTHER ISSUES WERE IDENTIFIED DURING THE INSPECTION. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED. CONCLUSION: AFTER A VISUAL INSPECTION PER GUIDANCE PROVIDED IN WINDCHILL DOCUMENT # 0000277191, IT IS DETERMINED THAT THE REUSABLE INSTRUMENTS ARE WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART # 289410300 LOT # 0209NT SUPPLIER: NORWOOD MEDICAL LOT RELEASED IN 6 BATCHES: BATCH # 1 - QTY - 49 RELEASE TO WAREHOUSE DATE: 17 FEB 2009 BATCH # 2 - QTY - 50 RELEASE TO WAREHOUSE DATE: 19 FEB 2009 BATCH # 3 - QTY - 55 RELEASE TO WAREHOUSE DATE: 19 FEB 2009 BATCH # 4 - QTY - 27 RELEASE TO WAREHOUSE DATE: 04 MAR 2009 BATCH # 5 - QTY - 32 RELEASE TO WAREHOUSE DATE: 05 MAR 2009 BATCH # 6 - QTY - 47 RELEASE TO WAREHOUSE DATE: 09 MAR 2009 NO NCR'S WERE GENERATED DURING PRODUCTION. 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. CORRECTED DATA: D9, G1, H3, H6.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE SURGEON USED THE SFX FINAL TORQUE SHAFT AND NOTED THAT IT WAS BURRED AND NEEDED TO BE REPLACED. THE SURGEON USED THE SECOND ONE ON THE SET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SFX X20 TORQUE DRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599130 SFX X20 TORQUE DRIVER SHAFT DRIVER, PROSTHESIS HWR DEPUY SPINE INC 289410300 0209NT 10705034224428

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR