BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X25 FINAL TIGHTENER

    MDR report key: 7484082 · Received May 3, 2018

    Report

    Report Number
    1526439-2018-50452
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 13, 2018
    Report Date
    April 13, 2018
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034199030
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION 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

    PRODUCT COMPLAINT # (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE CONFIRMS THAT 0.5MM OF THE HEX-LOBES ON THE DRIVERS¿ DISTAL TIP HAD BECOME STRIPPED. ALSO, THE OBSERVED DAMAGE NOTES THAT IT IS IN THE DIRECTION OF TIGHTENING. THIS DAMAGE IS CONSISTENT WITH A DRIVER THAT WAS ON AXIS, HOWEVER, NOT FULLY SEATED DURING USE. 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. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. THE ROOT CAUSE CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE OBSERVED DAMAGE IS LOCALIZED TO THE DISTAL TIP OF THE TIGHTENER DRIVE FEATURE SUGGESTING THAT A POSSIBLE ROOT CAUSE MAY LIKELY BE THAT THE SHAFT WAS ATTRIBUTED TO UNANTICIPATED TORSIONAL FORCES DURING TIGHTENING, RESULTING IN TIP BECOMING STRIPPED. 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 WERE FOUND, 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

    DATE OF EVENT: (B)(6) 2018. NAME OF REPORTER: (B)(6). HOSPITAL: (B)(6) HOSPITAL. SURGEON: MR (B)(6). HOSPITAL TOWN: (B)(6). PRODUCT NAME: EXPEDIUM VERSE X25. PRODUCT CODE : SEE BELOW FOR LOAN SETS AND ITEMS STRIPPED INCLUDING LOT NUMBERS. EXPEDIUM CORE INSTRUMENTS BUILD 1: VERSE X25 2997-04-230, GM4561901 + GM475601. EXPEDIUM CORE INSTRUMENTS BUILD 12: 2797-12-600, GM4489102. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? FRUSTRATION WAS CAUSED, WE CHANGED THE VERSE X25 AND THE SPARE WAS STRIPPED AS WELL. USED AN EXPEDIUM ONE AND THAT WAS STRIPPED. THE WAS ONE EXPEDIUM ONE THAT WAS NOT BUT THEN THE COUNTER-TORQUE WE HAD TO CHANGE AS DRIVER DIDN¿T FIT DOWN. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? THIS IS A LOAN SET SO PLEASE PHONE WAREHOUSE AND ORGANIZE THESE TO BE REPLACED OR THIS WILL HAPPEN AGAIN. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: ITEMS ABOVE STRIPPED CAUSING FRUSTRATION, WE CHANGED THE VERSE X25 AND THE SPARE WAS STRIPPED AS WELL. USED AN EXPEDIUM ONE AND THAT WAS STRIPPED. THE WAS ONE EXPEDIUM ONE THAT WAS NOT BUT THEN THE COUNTER-TORQUE WE HAD TO CHANGE AS DRIVER DIDN¿T FIT DOWN. FOR THIS MANY ITEMS TO BE STRIPPED IS SERIOUSLY DANGEROUS AS WE MIGHT NOT HAVE BEEN ABLE TO LOCK DOWN THE SET SCREWS. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED AS MR LUCAS IS EXTREMELY FRUSTRATED AND CONSIDERING MOVE COMPANIES IF THIS IS NOT SORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326996 X25 FINAL TIGHTENER DRIVER, PROSTHESIS HWR DEPUY SPINE INC 279712600 G0410 10705034199030

    Patients

    Seq Age Sex Outcome Treatment
    1