BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    MDR report key: 3647884 · Received February 26, 2014

    Report

    Report Number
    1719045-2014-00121
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES LOT NUMBER 6170571 & 5873442; SUPPLIER LOT NUMBER 15803-01. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. CRITERION INSTRUMENT MANUFACTURED THE DRIVE SHAFT ¿ MINIMUM 520MM, P/N 314.743, LOT # 6170571 & 5873442 (SUPPLIER LOT # 15803-01). SUPPLIER LOT # 15803-01: 99 PARTS, PER WORK ORDER. THE LOT CONFORMED TO P/N 314.743 SPECIFICATIONS, AS NOTED IN THE TWO CERTIFICATES OF COMPLIANCE (DATED MAY 04, 2011 AND SEPTEMBER 04, 2008). THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 314FI741. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 99 PARTS WERE RELEASED TO THE WAREHOUSE ON MAY 09, 2011. SUPPLIER LOT # 6170571, WORK ORDER INDICATES DESTROY LABEL / PACKAGING AS REQUIRED, PACK LABEL, RELEASE TO THE WAREHOUSE ON JUNE 24, 2009. SUPPLIER LOT # 5873442: PO FOR 99 PARTS. THE LOT CONFORMED TO P/N 314.743 SPECIFICATIONS, AS NOTED IN THE CERTIFICATE OF COMPLIANCE (DATED SEPTEMBER 04, 2008). THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 314IF741. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 99 PARTS WERE RELEASED TO THE WAREHOUSE ON SEPTEMBER 09, 2008. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE WITH THIRD PARTY PRODUCTS THE SURGEON WAS USING A SYNTHES REAMER IRRIGATOR ASPIRATOR WHEN THE INSTRUMENT BROKE APART INSIDE THE PATIENT. THE SURGEON WAS ABLE TO REMOVE EVERYTHING EXCEPT THREE PIECES OUT OF THE PATIENT. THE REPORTER WAS UNAWARE IF A FUTURE REVISION SURGERY WAS SCHEDULED TO EXPLANT THE REMAINING FRAGMENTS. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS A 30 MINUTE DELAY IN COMPLETING THE PROCEDURE DUE TO THE REPORTED EVENT. REGULAR REAMERS WERE USED AND A NAIL WAS PLACED IN THE BONE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118343 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 15803-01

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female