BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOD SQUARE EXP 5.5 SI DRIVER

    MDR report key: 9888204 · Received March 27, 2020

    Report

    Report Number
    1526439-2020-00791
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Report Date
    January 29, 2020
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HXX
    UDI-DI
    10705034473703
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DEEMED REPORTABLE AT THE CONCLUSION OF THE INVESTIGATION ON MARCH 11, 2019. REPORTER IS COMPANY REPRESENTATIVE. THE MOD SQUARE EXP 5.5 SI DRIVER (PART # 698341353/ LOT # GM54969MT) WAS RECEIVED AT US CQ. THE DEVICE WAS RECEIVED ASSEMBLED, THE DISTAL TIP OF THE DEVICE WAS CLEARLY BROKEN. NONE OF THE DRIVE FEATURE REMAINED. NO FRAGMENTS WERE RETURNED. THE OVERALL COMPLAINT WAS CONFIRMED DUE TO THE IDENTIFIED BROKEN CONDITION. DEVICE FAILURE/DEFECT IDENTIFIED? YES; DISTAL TIP OF THE DEVICE WAS BROKEN. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS). CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED MOD SQUARE EXP 5.5 SI DRIVER. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED, ITS POSSIBLE THE DEVICE EXPERIENCED UNINTENDED FORCES WHILE IN USE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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 HISTORY: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR THE MOD SQUARE EXP 5.5 SI DRIVER WAS CONDUCTED IDENTIFYING THAT LOT NUMBER GM54969MT WAS RELEASED IN TWO BATCHES. BATCH1: LOT QTY OF 4 UNITS WAS MANUFACTURED ON 3-SEP-2019. NR-0131782 WAS INITIATED DUE TO MATERIAL NOT MEETING REQUIRED CONDITION -DWG-103043189, NOTE 1: HEAT THREAT PER MPS-SOP-M/008 REV:12. IT WAS FOUND THAT THE SUPPLIER HAD MADE A DOCUMENTATION ERROR AND HAD RELEASED THE PRODUCT WITH THE WRONG PAPER CERTIFICATE WHICH IS WHY THIS WAS IDENTIFIED AS A NON-CONFORMANCE. THE SUPPLIER SENT THE APPROPRIATE PAPER-WORK, THIS NON-CONFORMANCE WAS RESOLVED AND DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION BATCH2: LOT QTY OF 4 UNITS WERE RELEASED ON 2-OCT-2019 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 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 AN UNKNOWN DATE, THE CUSTOM MADE EXPEDIUM POWEREASE DRIVER TIP STRIPPED OUT DURING SCREW INSERTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351245 MOD SQUARE EXP 5.5 SI DRIVER SCREWDRIVERES HXX DEPUY SPINE INC 698341353 GM54969MT 10705034473703

    Patients

    Seq Age Sex Outcome Treatment
    1