BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2962960 · Received February 15, 2013

    Report

    Report Number
    1719045-2013-00327
    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
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: ADDITIONAL INFORMATION. ADDITIONAL PRODUCT CODE: HRX. 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 (B)(4) 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. (B)(4). 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. CRITERION TOOL AND DIE, INC. MANUFACTURED THE DRIVE SHAFT. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL SPECIFICATIONS AT THE TIME OF MANUFACTURE AND THERE WERE NO NON CONFORMITIES NOTED. 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 1 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66712 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA DRIVE SHAFT HTO SYNTHES MONUMENT 13892-01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR