BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM FLEXSHAFT

    MDR report key: 2874037 · Received December 14, 2012

    Report

    Report Number
    8030965-2012-01572
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    August 7, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS OF THE FLEXIBLE SHAFT WERE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD FOR NITINOL, (B)(4). NO PRODUCT FAULT COULD BE DETECTED. BASED ON THE COMPLAINT DESCRIPTION AND WITHOUT THE BROKEN REAMER HEAD WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD DURING REAMING CAUSED THE BREAKAGE OF THE REAMER HEAD.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A FEMORAL REAMING FOR A TOTAL HIP PROSTHESIS, THE REAMER HEAD DISCONNECTED FROM THE FLEXIBLE SHAFT. THE REAMER HEAD REMAINS IN THE FEMUR OF THE PATIENT AS IT WAS NOT POSSIBLE TO REMOVE IT WITHOUT PERFORMING AN OSTEOTOMY. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNREAM FLEXSHAFT SYNREAM FLEXSHAFT HTO SYNTHES GMBH 2090793

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR REAMER HEAD