BEUDAMED
    FDA Adverse Event Summary report: N

    SCHUK FLPL-SS WIRE PIST [ORIG ITEM: 140126]

    MDR report key: 5568074 · Received April 11, 2016

    Report

    Report Number
    1519132-2016-00002
    Date Received
    April 11, 2016
    Date of Event
    February 1, 2016
    Report Date
    May 13, 2016
    Manufacturer
    OSTA
    Product Code
    ETA
    PMA / PMN Number
    PK760433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, WE WERE NOTIFIED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION METHODS/DETAILS: THE CUSTOMER COMPLAINT OF THE WIRE SEPARATING FROM THE PROSTHESIS WAS CONFIRMED. A REVIEW OF THE RETURNED COMPONENTS FOUND ONLY THE TEFLON PORTION P/N: 1171031 HAD BEEN RETURNED COMPLETELY MISSING THE WIRE P/N: 9220188. THE DHR FOR IH898085 AND IH899881 WERE BOTH REVIEWED AND FOUND NO ABNORMALITIES. A FURTHER REVIEW WAS CONDUCTED ON THE TEFLON BLANK ASSEMBLY P/N: 1171031 MH883120 DHR AS WELL AS THE RECEIPT TICKET FOR THE RAW STOCK MATERIAL P/N: 035060 LOT# 71152. NO ABNORMALITIES WERE FOUND IN THESE DOCUMENTS EITHER. THE PROCESS WAS REVIEWED AND THE WIRE IS MOLDED TO THE TEFLON PISTON AFTER AN ANCHOR IS MADE AT THE END OF THE WIRE TO SECURE IT INSIDE OF THE PISTON. TESTING OF EXISTING 140126-ENT LOT# SD994735 PRODUCT LOCATED WITHIN BARTLETT INVENTORY WAS PULL TO FAILURE TO DETERMINE WHAT FORCE WAS REQUIRED TO REMOVE THE WIRE FROM THE PISTON. THE AVERAGE STRENGTH WAS DETERMINED TO BE 0.307 LBF. AS THIS IS A LEGACY ITEM THERE IS LITTLE HISTORICAL DATA AVAILABLE TO COMPARE AGAINST. A COMPLAINT REVIEW WAS CONDUCTED FOR THE LAST 3 YEARS AND THIS IS THE FIRST REPORTED FAILURE OF THE WIRE DETACHING FROM THE PISTON. CONCLUSION SUMMARY/RESULTS: SUMMARY OF INVESTIGATION FIND THAT THE CUSTOMER'S COMPLAINT OF A SEPARATED WIRE WAS CONFIRMED. AS THIS WAS A LEGACY PRODUCT FURTHER ANALYSIS IS BEING PERFORMED ON WIRE RETENTION CAPABILITIES.

    Description of Event or Problem · 1

    THIS WAS A THERAPEUTIC PROCEDURE. INTENDED PROCEDURE WAS REMOVAL OF THE ENTIRE PROSTHESIS. INDICATION FOR THE OPERATION WAS BAD HEARING AND DIZZINESS. OPERATOR PUT SLIGHT TRACTION ON THE STAINLESS STEEL WIRE IN ORDER TO REMOVE THE PISTON. THE WIRE CAME LOOSE FROM THE PISTON. THE PROCEDURE WAS CANCELED, THE PATIENT WAS TRANSFERRED TO (B)(6). PISTON WAS REMOVED BY LASER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223239 SCHUK FLPL-SS WIRE PIST [ORIG ITEM: 140126] WIRE PISTON ETA OSTA 140126-ENT IH898085

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R