BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5047057 · Received September 1, 2015

    Report

    Report Number
    1719045-2015-10568
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING DATES INCLUDE JUNE 24, 2009. DEVICE HISTORY REVIEW: CRITERION TOOL & DIE MANUFACTURED THE DRIVE SHAFT, MINIMUM 520MM LENGTH, FOR USE WITH RIA (PART 314.743 / LOT 15803-01) FOR 99 PARTS FOR ONE WORK ORDER AND 99 PARTS FOR ANOTHER. THE REWORK FORM (DATED (B)(4) 2011) INDICATED ¿ETCH ¿CE¿ MARK AND PASSIVATE. REWORK OF CRITERION MANUFACTURED PART 314.743 / LOT 5873442 (ORIGINAL LOT 6170571, REPACKED BY SYNTHES). THE CERTIFICATE OF COMPLIANCE (C OF C), DATED MAY 4, 2011, INDICATES LOT 15803-01 WAS PASSIVATED PER THE SYNTHES DRAWING. THE SECOND C OF C (DATED SEPTEMBER 4, 2008) INDICATED THE LOT WAS MANUFACTURED AND CONFORMED TO SPECIFICATIONS PER THE ASSOCIATED SYNTHES DRAWING. LOT 15803-01 WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION TABULATED SHEET. THERE WERE NO COMPLAINT-RELATED ISSUES, MATERIAL RECORD REPORTS, OR NON-CONFORMANCE REPORTS ASSOCIATED WITH THIS LOT. 99 PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2011. LOT 6170571 FOR 99 PARTS WAS FOR ¿DESTROY LABEL / PACKAGE AS REQUIRED, PACK / LABEL PER LPPF¿, AND INDICATED 99 PARTS WERE RELEASED TO THE WAREHOUSE ON JUNE 24, 2009. DEVICE 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS REQUESTED FOR THE SUBJECT DEVICE LOT. IT WAS REPORTED THAT THE SUBJECT DEVICE WOULD NOT BE RETURNED FOR EVALUATION. 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 DURING A TROCHANTERIC FIXATION NAIL INSERTION, WHILE THE SURGEON WAS REAMING WITH THE POWER IN REAM MODE, THE TIP OF THE DRIVE SHAFT BROKE OFF. IT WAS REPORTED THAT THE PATIENT HAD HARD BONE. A STANDARD REAMER WAS IMMEDIATELY AVAILABLE TO COMPLETE THE PROCEDURE. THE TIP WAS REMOVED AND NO FRAGMENTS WERE RETAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577457 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 15803-01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR