BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA

    MDR report key: 3655261 · Received March 3, 2014

    Report

    Report Number
    1719045-2014-00123
    Event Type
    Malfunction
    Date Received
    March 3, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 3, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AT TIME OF EVENT: (B)(6). PATIENT SEX: FEMALE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS INTENDED FOR TREATMENT, NOT DIAGNOSIS.SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN.(B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. A MANUFACTURING EVALUATION WAS CONDUCTED WITH THE FOLLOWING CONCLUSION: CRITERION TOOL & DIE MANUFACTURED THE RIA DRIVE SHAFT ASSEMBLY L360, P/N 314.742, AND LOT NUMBER 6027929 (SUPPLIER LOT # 15963-01). THE COMPLAINT CONDITION (BROKEN TIP) IS DUE TO AN UNKNOWN CAUSE. THE LOT INITIALLY CONFORMED TO ALL REQUIREMENTS PER THE CERTIFICATES OF CONFORMANCE AND COMPLIANCE AND WAS INSPECTED / CONFORMED TO THE SYNTHES TABULATED INCOMING FINAL INSPECTION. BASED ON THE EVALUATION PERFORMED AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT ¿ MINIMUM 360MM LENGTH ¿ FOR USE WITH RIA (REAMER / IRRIGATOR / ASPIRATOR) P/N 314.742, LOT # 6027929 (SUPPLIER LOT # 15963-01). THE CERTIFICATE OF COMPLIANCE, DATED NOVEMBER 07, 2008, WAS MADE TO DRAWING NUMBER 314.742 AND INDICATED THE LOT CONFORMED TO SPECIFICATIONS. THE 21-PART LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 314FI741. THERE WERE NO MRR, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. 21 PARTS WERE RELEASED TO THE WAREHOUSE ON NOVEMBER 13, 2008. EVENT REPORTED AS A PRODUCT MALFUNCTION. NO REPORT OF PATIENT HARM, ADDITIONAL MEDICAL/SURGICAL INTERVENTIONS, OR DELAY IN SURGERY. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT EVALUATION: THE REAMER IRRIGATOR ASPIRATOR RIA DRIVE SHAFT, STERILE TUBE AND REAMER HEAD ARE USED IN CONCERT WITH THE SYNTHES RIA. DRAWING 314_743 REV. J WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. TECHNIQUE GUIDE J4352-H CLEARLY STATES THAT POWER DRIVERS WITH GREATER THAN 6NM OF TORQUE SHALL NOT BE USED WITH THIS INSTRUMENT. PREVIOUS COMPLAINTS HAVE INDICATED THAT 3RD PARTY DRIVERS HAVE BEEN UTILIZED IN THESE REAMING PROCEDURES. BASED ON THE AVAILABLE INFORMATION IN THIS COMPLAINT, THE DEVICE IS DETERMINED TO BE SUITABLE FOR ITS INTENDED USE WHEN USED AS RECOMMENDED AND THE COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    (B)(4) RECEIVED ON (B)(4) 2014. CORRECTED AND ADDITIONAL INFORMATION WILL BE PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127788 DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA HTO SYNTHES MONUMENT 15963-01

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR