BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4226111 · Received November 5, 2014

    Report

    Report Number
    1719045-2014-10558
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 9, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: CRITERION TOOL & DIE, INC. MANUFACTURED THE DRIVE SHAFT ASSEMBLY FOR (B)(4), PART NUMBER 314.742, AND LOT NUMBER 5423190 (SUPPLIER LOT 14664-01). INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE AND SYNTHES FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: UPON RECEIPT OF THE DEVICE, IT WAS NOTED THAT THE TIP IS BROKEN; ONLY ONE FRAGMENT IS WITH THE COMPLAINT. ALL MEASURABLE PARAMETERS MEET SPECIFICATION. SINCE THE TIP IS BROKEN, THE CAUSE OF FAILURE IS NOT APPARENT, ALTHOUGH METAL FATIGUE IS LIKELY. BASED ON THE EVALUATION, THE COMPLAINT CONDITION IS CONFIRMED BUT IS NOT CONSIDERED TO BE MANUFACTURING RELATED. 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 THAT DURING THE SURGERY, THE SURGEON CHANGED THE REAMER HEAD FROM THIS DEVICE SEVERAL TIMES. DURING ONE OF THOSE CHANGES, THE DISTAL PART OF THE TRANSMISSION OF THE DEVICE BROKE. THERE WAS ABOUT A TEN MINUTE DELAY IN SURGERY. THE PATIENT STATUS IS REPORTED AS OKAY. THEY HAD A SECOND DEVICE AND THEY USED IT TO FINISH THE OPERATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708895 DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 14664-01

    Patients

    Seq Age Sex Outcome Treatment
    1