BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMSI FINAL TIGHTENER

    MDR report key: 6011797 · Received October 7, 2016

    Report

    Report Number
    1526439-2016-10747
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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

    MODEL/LOT #, DEVICE MANUFACTURE DATE: ADDITIONAL INFORMATION. DEVICE EVALUATED BY MFR?, EVALUATION CODES: CORRECTED DATA. (B)(4). THE MOSS MIAMI SINGLE INNIE FINAL TIGHTENER (PRODUCT CODE: 2797-12-600, LOT NUMBER:GM3828503) WAS NOT RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU). AND AN IMAGE OF THE FINAL TIGHTENER WERE RETURNED TO THE CHU ON OCTOBER 14TH, 2016 AFTER THE ORIGINAL CLOSURE OF THE COMPLAINT. THE LOT NUMBER OF THE TIGHTENER WAS DETERMINED TO BE GM3828503. A RETURNED IMAGE OF THE DRIVER TIP FEATURED STRIPPING TO THE HEXLOBES. THE STRIPPING APPEARS TO EXTEND DOWN APPROXIMATELY ONE FIFTH OF THE TOTAL LENGTH OF THE DISTAL END OF THE DRIVER¿S HEXLOBES. ALTHOUGH THE RETURNED IMAGE PROVIDES A LIMITED AMOUNT OF DETAIL, THE STRIPPING APPEARS TO HAVE OCCURRED IN THE DIRECTION OF ROTATION. THIS DAMAGE COULD POTENTIALLY OCCUR IF THE INSTRUMENT IS NOT FULLY INSERTED INTO AND FLUSH WITH THE SET SCREW DURING TIGHTENING. THE TORQUE IS INSTEAD APPLIED TO A LIMITED SURFACE AREA, DAMAGING THEIR HEXLOBES IN THE PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE DRIVER TIP STRIPPING CANNOT BE DETERMINED FROM THE IMAGE AND INFORMATION AVAILABLE. A POTENTIAL ROOT CAUSE MAY BE HAVING THE TIP OF THE TIGHTENER FULLY INSERTED INTO AND FLUSH WITH THE DRIVE FEATURE OF A SET SCREW DURING TIGHTENING. THIS WOULD CAUSE TORQUE TO BE APPLIED TO A LIMITED SURFACE AREA, DAMAGING ITS HEXLOBES IN THE PROCESS. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS REQUIRING IMMEDIATE ACTION HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    PROCEDURE: INSTRUMENTATED POSTERIOR LUMBER FUSION. X25 FINAL TIGHTENER TIP BECAME BURRED WITH USE. IMMEDIATELY REPLACED WITH A SECOND X25 FINAL TIGHTENER INSTRUMENT FROM THE EXPEDIUM SET FROM THE SET. CASE DELAYED BY 1-2 MINUTES. PROCEDURE CONTINUED AS EXPECTED, NO ADVERSE EVENT TO PATIENT. NO FURTHER INFORMATION AVAILABLE. PRODUCT DISCARDED = NO RETURN TO MANUFACTURER UNLESS LOCAL ENGINEERING ASSESSMENT INDICATES RETURN IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663310 MMSI FINAL TIGHTENER DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE GM3828503

    Patients

    Seq Age Sex Outcome Treatment
    1