BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINDLE FOR EVOLUTION

    MDR report key: 6414633 · Received March 17, 2017

    Report

    Report Number
    1719045-2017-10233
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Report Date
    February 25, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10705034732022
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING INVESTIGATION AND PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE RETURNED SUBJECT DEVICE. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, MANUFACTURING INVESTIGATION, AND PRODUCT DEVELOPMENT INVESTIGATION WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION CAN BE REPLICATED THEREFORE THE COMPLAINT IS CONFIRMED. THE INSTRUMENT (03.825.002, LOT H055338, QTY 1) WAS RETURNED BECAUSE THE WELD WAS REPORTED TO BE CRACKED. THE WELD ON THE KNOB HAS A HAIRLINE CRACK ALMOST ALL AROUND (~350°). THE BACK OF THE KNOB HAS VISIBLE SIGNS OF IMPACTION. THE KNOB DOES NOT SEPARATE AND IS ABLE TO APPLY TORQUE AS INTENDED. THERE ARE NO VISIBLE SIGNS OF DAMAGE ON THE SHAFT OR M4 AND M8 THREADS. BASED ON THE OBSERVATIONS, IT IS LIKELY THAT THE SIZE OF THE WELD DID NOT HAVE ENOUGH STRENGTH FOR THE APPLIED IMPACTION LOADS. THE 03.825.002 SYNCAGE EVOLUTION SPINDLE IS AN INSTRUMENT ROUTINELY USED IN THE SYNCAGE EVOLUTION SYSTEM. THE SPINDLE INSTRUMENT (03.825.002) IS DESIGNED TO MATE WITH THE SYNCAGE EVOLUTION (03.815.001) AND SYNFIX EVOLUTION (03.835.100) HOLDERS. THE KNOB WILL BE IMPACTED TO INSERT A TRIAL SPACER. PART WAS EXAMINED UNDER MAGNIFICATION AND FOUND TO BE WELDED PER PRINT. WELD WAS CRACKED COMPLETELY THROUGH THE CENTER, THIS TELLS US FORCE OR BENDING WAS APPLIED BEYOND ITS CAPABILITY. NOTE: 465 WELDED CAN BE BRITTLE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. BASED ON THE OBSERVATIONS, IT IS LIKELY THAT THE SIZE OF THE WELD DID NOT HAVE ENOUGH STRENGTH FOR THE APPLIED IMPACTION LOADS. APPROPRIATE ACTIONS HAVE BEEN TAKEN TO DETERMINE IF FURTHER ACTION IS REQUIRED AS A RESULT OF THE VALID DESIGN ISSUE. 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

    ADDITIONAL NARRATIVE: DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # 03.825.002, LOT # H055338. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: JULY 18, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    SERVICE AND REPAIR REPORTED A SPINDLE FROM AN EVALUATION SET WAS BROKEN. IT IS UNKNOWN WHEN THE DEVICE BROKE; HOWEVER, NO PATIENT INVOLVEMENT WAS REPORTED. THE ISSUE WAS IDENTIFIED DURING ROUTINE INSPECTION ACTIVITIES OF THE SET. NO ISSUES WERE REPORTED BY THE FACILITY. THIS REPORT IS FOR ONE (1) SPINDLE FOR EVOLUTION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195925 SPINDLE FOR EVOLUTION MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT H055338 10705034732022

    Patients

    Seq Age Sex Outcome Treatment
    1