BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2928780 · Received January 24, 2013

    Report

    Report Number
    1719045-2013-00185
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K013527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT 5843459, VENDOR LOT 15685-01, REVEALED THE DRIVE SHAFT ASSEMBLY WAS MANUFACTURED BY CRITERION TOOL AND DIE. PARTS WERE INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET AND THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    A PORTION OF THE HEX TIP WHICH COUPLES WITH THE REAMER HEAD RECESS HAS BEEN BROKEN OFF AND THE HELIX HAS BEEN SIGNIFICANTLY WORN DOWN. THE BROKEN TIP WAS NOT RETURNED FOR EVALUATION. THE FRACTURE IS JAGGED. THE HELIX LOCATED ABOVE THE HEX IS WORN DOWN WHICH CAUSED THE DRIVE SHAFT TO FAIL. THE DESIGN WAS UPDATED ON (B)(4) 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 IN (B)(4) HAD AN 82 PERCENT 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 H FROM 304 STAINLESS STEEL IN AUGUST 2008 AFTER THE DESIGN CHANGE TO REVISION J. HOWEVER, THE DCO DISPOSITIONED ALL INVENTORY, WIP, RAW MATERIAL, RECEIPTS ROUTING AND PURCHASE ORDERS USE AS IS. THIS DEVICE IS USED REPEATEDLY, SO THE ACTUAL COMPLAINT RATE BASED ON USAGE WOULD BE SIGNIFICANTLY LOWER. THE RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM OF THREE AND AN IMPROBABLE PROBABILITY OF OCCURRENCE ONE.

    Description of Event or Problem · 1

    DURING A REAMING PROCEDURE OF THE FEMUR THE REAMER SHAFT BROKE. ALL PIECES WERE RETRIEVED AND SURGEON SELECTED ANOTHER SHAFT AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34397 DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA DRIVE SHAFT HTO SYNTHES MONUMENT 15685-01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR DRIVE, SHAFT, REAMER HEAD