BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 7136720 · Received December 20, 2017

    Report

    Report Number
    2939274-2017-50390
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Report Date
    November 24, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982196064
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE RETURNED TO MANUFACTURER. DHR REVIEW WAS COMPLETED. PART NUMBER: 357.372 SYNTHES LOT NUMBER: 7812863, SUPPLIER LOT NUMBER: YYYYY. RELEASE TO WAREHOUSE DATE: 09 DEC 2014. SUPPLIER: JENNERSVILLE INSTRUMENTS. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NCRS WERE GENERATED DURING PRODUCTION. SERVICE AND REPAIR EVALUATED THE RETURNED DEVICE. THE CUSTOMER REPORTED THE END DISK OF THE INSERTER BROKE, AND THE SIDE SCREW AND INSIDE PIN NO LONGER FUNCTIONED. THE REPAIR TECHNICIAN REPORTED THE ALIGNMENT INDICATOR WAS MISSING. MISSING PARTS IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THE FOLLOWING PARTS WERE REPLACED: REPLACEMENT ALIGNMENT. THE ITEM WAS REPAIRED PER THE INSPECTION SHEET, PASSED SYNTHES FINAL INSPECTION ON 18-DEC-2017 AND WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE EVALUATION WAS CONFIRMED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 357.372 WITH LOT NUMBER(S) 7812863 IS A LOT/BATCH CONTROLLED ITEM. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE END DISK OF THE HELICAL BLADE INSERTER BROKE AFTER DISMANTLING OF THE INSTRUMENT FOR CLEANING. THE SIDE SCREW AND THE INSIDE PIN NO LONGER FUNCTION. NO PATIENT INVOLVEMENT.THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912802 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 7812863 10886982196064

    Patients

    Seq Age Sex Outcome Treatment
    1