BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO HANDLE TORQ LIMITING 3.0NM

    MDR report key: 11301320 · Received February 9, 2021

    Report

    Report Number
    1526439-2021-00260
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 20, 2021
    Report Date
    January 20, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    LXH
    UDI-DI
    10705034532813
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H3, H4, H6: DEVICE HISTORY LOT A REVIEW OF THE RECEIVING INSPECTION (RI) FOR AO HANDLE TORQ LIMITING 3.0WAS CONDUCTED IDENTIFYING THAT LOT NUMBER KM881265 WAS RELEASED IN FOUR BATCHES. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON 21 FEB 2020 WITH NO DISCREPANCIES. BATCH2: LOT QTY OF (B)(4) UNITS WERE RELEASED ON 13 MAR 2020 WITH NO DISCREPANCIES. BATCH3: LOT QTY OF (B)(4) UNITS WERE RELEASED ON 21 FEB 2020 WITH NO DISCREPANCIES. BATCH4 : LOT QTY OF (B)(4) UNITS WERE RELEASED ON 13 MAR 2020 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. INVESTIGATION SUMMARY BACKGROUND: IT WAS REPORTED THAT ON JANUARY 20, 2021, DURING POSTERIOR SPINAL FUSION SURGERY THE SYMPHONY 3.0 TORQUE HANDLE WOULD NOT TORQUE. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY TIGHTENING TACTICAL (FEEL AND SOUND). THIS COMPLAINT INVOLVES ONE (1) DEVICE. INVESTIGATION FLOW: POWER TOOLS/CALIBRATION VISUAL INSPECTION: THE AO HANDLE TORQ LIMITING 3.0 NM (P/N: 202000504, LOT #: KM881265) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, NO ISSUES WERE OBSERVED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST WAS PERFORMED ON THE RETURNED DEVICE AT COMPLAINTS DEPARTMENT. RAYNHAM, MA. THE HIGHEST TORQUE OF THE DEVICE MEASURED DURING CALIBRATION TESTING WAS 3.279 NM WHICH WAS NOT WITHIN THE SPECIFIED TORQUE RANGE OF THE DEVICE OF 2.75 NM - 3.25 NM PER DRAWING NUMBER 103327943, REV. D. HENCE, THE TORQUE TEST FAILED HIGH. PLEASE REFER TO "(B)(4) PD INVESTIGATION REPORT" IN THE ATTACHMENTS FOR TORQUE TEST RESULTS. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT DEVICE FAILED IN CALIBRATION TEST. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. TORQUE LIMITING HANDLE 3.0 NM : 103327943, REV. D. COMPLAINT WAS CONFIRMED. THE DEVICE RECEIVED FAILED IN CALIBRATION TESTING. HENCE, CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED AS THE 3.0 NM TORQUE LIMITING HANDLE WITH 4.5 MM QUICK COUPLING (P/N: 03.632.204,LOT # 6601894) FAILED HIGH IN CALIBRATION TEST. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE BREAKAGE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IT WAS REPORTED THAT ON (B)(6) 2021 DURING A POSTERIOR SPINAL FUSION SURGERY THE SYMPHONY 3.0 TORQUE HANDLE WOULD NOT TORQUE. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY TIGHTENING TACTICALLY USING FEEL AND SOUND. THIS REPORT IS FOR ONE (1) AO HANDLE TORQ LIMITING 3.0NM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196276 AO HANDLE TORQ LIMITING 3.0NM MISC ORTHO SURGICAL INSTR LXH DEPUY SPINE INC 2020-00-504 KM881265 10705034532813

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR AO HANDLE TORQ LIMITING 3.0NM