BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR

    MDR report key: 2962959 · Received February 15, 2013

    Report

    Report Number
    1719045-2013-00325
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE HELIX LOCATED ABOVE THE HEX IS WORN DOWN WHICH CAUSED THE DRIVE SHAFT TO FAIL. THE DESIGN WAS UPDATED IN MAY 2008 TO REVISION J WHICH CHANGED THE RIA DRIVE SHAFT HELIX COMPONENT FROM 304 STAINLESS STEEL TO 316L STAINLESS STEEL WITH KOLSTERIZATION. THIS CHANGE IMPROVED THE RESISTANCE TO WEAR OF THE DRIVE SHAFT HELIX COMPONENT. DESIGN VERIFICATION TESTING WAS PERFORMED WHICH SHOWED THAT DRIVE SHAFT HELIX SAMPLES INCORPORATING THE DESIGN CHANGE PROPOSED HAD AN 82% IMPROVEMENT IN WEAR RESISTANCE WHEN COMPARED TO THE PREVIOUS DESIGN AFTER EXPOSURE TO BENCH TESTING WHICH SIMULATE PRODUCT USE. THE RETURNED DEVICE WAS MANUFACTURED TO REVISION D FROM 304 STAINLESS STEEL IN JUNE 2005 PRIOR TO THE DESIGN CHANGE. THIS DEVICE IS USED IN MULTIPLE PROCEDURES AND IS REUSABLE. AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HISTORY REVIEW COULD NOT BE COMPLETED WITH THE NUMBERS GIVEN IN THE COMPLAINT. THE LOT NUMBER DOCUMENTS COULD NOT BE FOUND. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING A TFN NAIL PROCEDURE: WHILE REAMING CANAL FOR IM NAIL, REAMER SHAFT WOULD NOT STAY FULLY ENGAGED WITH RIA DISPOSABLE REAMING TUBE; WHEN SURGEON TRIED TO RE ENGAGE SHAFT WITH TUBE, THE REAMER HEAD POPPED OFF INTO CANAL. FRAGMENTS OF THE TIP WERE RETRIEVED FROM THE SOFT TISSUE WITH POSSIBLE FRAGMENTS IN THE CANAL. ONCE THE FRAGMENTS WERE RETRIEVED, SURGEON HAD TO USE A REGULAR FLEXIBLE REAMER TO COMPLETE THE PROCEDURE. SURGEON IMPLANTED THE NAIL WITH NO FURTHER PROBLEMS. THE SURGERY WAS EXTENDED 10 TO 15 MINUTES. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68749 13.0MM REAMER HEAD-STERILE FORREAMER/IRRIGATOR/ASPIRATOR REAMER HEAD-STERILE HTO SYNTHES MONUMENT UN 38941

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR