BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 5659598 · Received May 17, 2016

    Report

    Report Number
    1719045-2016-10408
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 18, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PK111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS ARE (B)(6). THE PATIENT WEIGHT IS UNKNOWN. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HRX. UDI NUMBER: (B)(4). IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY RECORD REVIEW: PACKAGED BY: (B)(4) - MANUFACTURING DATE: JANUARY 22, 2016 - EXPIRATION DATE: DECEMBER 31, 2024 NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. DEVICE 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

    DEVICE 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 REAMER/IRRIGATOR/ASPIRATOR (RIA) SHAFT DISLODGED FROM THE RIA HEAD DURING AN INTRAMEDULLARY NAILING PROCEDURE OF THE FEMUR ON (B)(6) 2016. THE ISSUE REPORTEDLY OCCURRED AS THE SURGEON WAS REAMING THE FEMUR. THE SURGEON TRIED TO RE-CONNECT THE DEVICES, BUT THEY WOULD NOT FULLY SEAT. THE RIA WAS SPUN AROUND AND THE TIP OF THE SHAFT BROKE. THE BROKEN TIP WAS REMOVED FROM THE PATIENT WITH EASE. THE SURGEON STOPPED REAMING AND SUCCESSFULLY IMPLANTED THE NAIL. THERE WAS A 30-40 SECONDS DELAY IN SURGERY, BUT IT WAS ULTIMATELY COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: DRIVE SHAFT SEAL (PART 351.718S, LOT 9973396, QUANTITY: 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314146 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR REAMER HTO SYNTHES MONUMENT 9957216

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR