BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE LIMITING HANDLE 80IN-LB

    MDR report key: 10140753 · Received June 10, 2020

    Report

    Report Number
    1526439-2020-01154
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 29, 2020
    Report Date
    May 29, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    LXH
    UDI-DI
    10705034467399
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. D10: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H6: 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 · 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. H3, H4, H6: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR VERSE 3IN1 DRIVER, TORQUE WR WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GB100468 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON JANUARY 5, 2017 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. THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. VISUAL INSPECTION: THE TORQUE LIMITING HANDLE 80 IN-LB (P/N: 299704320, LOT #: GB100468 ) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THERE WEE NO DEFECTS FOUND ON THE DEVICE. FUNCTIONAL TEST: THE FUNCTIONAL TEST WAS PERFORMED BY NPD LAB ON 9/16/2020. THE LOWEST TORQUE OF THE DEVICE MEASURED DURING CALIBRATION TESTING WAS 77.50 IN-LB AND 87.54 IN-LB HIGH WHICH ARE WITHIN THE SPECIFIED TORQUE RANGE OF THE DEVICE OF 80 IN-LBS +/-10% (72 IN-LB TO 88 IN-LB). HENCE, THE COMPLAINT CONDITION CANNOT BE CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. COMPLAINT CONFIRMED? NO, THE DEVICE TESTED WITHIN THE RANGE DURING THE TORQUE TEST. HENCE NOT CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE TORQUE LIMITING HANDLE 80 IN-LB (P/N: 299704320, LOT # GB100468 ). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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 ON AN UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT FOR A REVISION SURGERY FOR A THORACOLUMBAR FUSION DUE TO INFECTION AND EXPERIENCED SEVERAL EQUIPMENT ISSUES. THE SURGEON WAS UPSIZING A PEDICLE SCREW TO AN EXPEDIUM SCREW AND THE TIP OF THE SCREWDRIVER WAS BREAK OFF WHILE ADVANCING THE SCREW. THE SURGEON USED INSTRUMENTS FROM THE SPINE SCREW REMOVAL SET TO ATTEMPT TO REMOVE THE SCREW BUT WAS UNABLE TO. THE SURGEON ENDED UP CUTTING THE SCREW OFF WITH A HIGH-SPEED DRILL TO REMOVE. PRIOR TO REVISION SURGERY THE PATIENT ALSO HAD MULTIPLE UNITIZED SET SCREWS BACK OUT OF SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-20 MINUTES DELAY. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ANY ADDITIONAL INTERVENTION. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603963 TORQUE LIMITING HANDLE 80IN-LB MISC ORTHO SURGICAL INSTR LXH MEDOS INTERNATIONAL SàRL CH 299704320 GB100468 10705034467399

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN EXTRACTION INSTRUMENTS| UNKNOWN SCREWS| XPDM QUICK-CON SI POLY SCWDRVR