BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6205947 · Received December 27, 2016

    Report

    Report Number
    1719045-2016-10946
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    UDI-DI
    10886982189042
    PMA / PMN Number
    K042899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS THE DEVICE WAS REPORTEDLY DISCARDED BY THE FACILITY. (B)(4). RELEASE TO WAREHOUSE DATE: APRIL 03, 2015. SUPPLIER: CRITERION TOOL & DIE, INC. NO NON-CONFORMANCE REPORTS 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 A PATIENT WAS INITIALLY IMPLANTED WITH NON-SYNTHES DEVICES ON (B)(6) 2016 DUE TO A MOTOR VEHICLE ACCIDENT. ON (B)(6) 2016, THE DEVICES WERE EXPLANTED FOR AN INFECTION OF THE TIBIA. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2016 FOR A PLANNED SAUCERIZATION OF THE TIBIA TO FACILITATE DRAINAGE FROM THE AFFECTED AREA AND NO DEVICES WERE IMPLANTED. AS THE SURGEON WAS USING THE REAMER, IRRIGATOR AND ASPIRATOR (RIA) SYSTEM, APPROXIMATELY EIGHT TO TEN CENTIMETERS (8-10CM) OF THE TIP OF THE DRIVE SHAFT BROKE HALF WAY THROUGH THE REAMING PROCESS. IT WAS REPORTED THAT THE FRAGMENT WAS EASILY RETRIEVED AS THE DRIVE SHAFT IS CONTAINED INSIDE THE ASSEMBLY. HOWEVER, AN UNANTICIPATED X-RAY WAS TAKEN TO ENSURE THAT NO FRAGMENTS REMAINED IN THE PATIENT. THE SURGEON FINISHED THE PROCEDURE BY USING THE FLEXIBLE REAMER USED FOR INTRAMEDULLARY NAILS. THERE WAS A THREE (3) MINUTE DELAY DUE TO THE ISSUE. THE REMAINDER OF THE SURGERY WAS UNEVENTFUL AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICE: REAMER HEAD (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854857 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA REAMER HTO SYNTHES MONUMENT 7773993 10886982189042

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention 1 UNKNOWN REAMER HEAD