BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6700469 · Received July 11, 2017

    Report

    Report Number
    1719045-2017-10644
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    June 14, 2017
    Report Date
    June 14, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S HEIGHT REPORTED AS 180 CM. ADDITIONAL DEVICE PRODUCT CODE: HRX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 314.743, LOT # 9910153: RELEASE TO WAREHOUSE DATE: 16-OCT-2015, EXPIRATION DATE: NA, SUPPLIER: (B)(4): NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    IT WAS REPORTED THAT DURING ORIGINAL OPEN REDUCTION INTERNAL FIXATION OF PROXIMAL TIBIAL PLATEAU PROCEDURE ON (B)(6) 2017, WHILE CHANGING REAMER HEAD OF DIFFERENT SIZE, THE TIP OF THE REAMER IRRIGATOR ASPIRATOR (RIA) SHAFT BROKE. FRAGMENTS WERE NOT GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS REPORTED AS STABLE POST OPERATIVELY. CONCOMITANT DEVICES REPORTED: REAMER HEAD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) DRIVE SHAFT-MINIMUM 520MM LENGTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480491 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 314.743 9910153 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR