BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40(TM). RASP HANDLE

    MDR report key: 2979790 · Received February 27, 2013

    Report

    Report Number
    0002249697-2013-00777
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING AN EXETER RASP HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. THE RETURNED INSTRUMENT IS DAMAGED, THERE ARE DEEP IMPACTS. THE LATCH OF THE TRIGGER IS BROKEN AND THE LATCH WAS NOT RETURNED FOR EVALUATION. THERE IS A FISSURE (CRACK) NEAR THE LOCKING MECHANISM ON THE BODY OF THE INSTRUMENT. THE LOCKING LATCH FRACTURE WAS CONSISTENT WITH A STRAIGHT TENSION OVERLOAD. THE REPORTED EVENT WAS NOT RELATED TO A CLINICAL SITUATION. THERE WERE NO SURGICAL DELAYS AND NO ADVERSE CONSEQUENCES NOTED TO THE PATIENT. DEVICE HISTORY RECORDS FOR THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN 2 OTHER EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED HOWEVER BOTH THE MAR REPORT AND THE SUPPLIER INVESTIGATION CONCLUDED THAT THE RETURNED INSTRUMENT IS DAMAGED, THERE ARE DEEP IMPACTS. THE LATCH OF THE TRIGGER IS BROKEN AND THE LATCH WAS NOT RETURNED FOR EVALUATION. THERE IS A FISSURE (CRACK) NEAR THE LOCKING MECHANISM ON THE BODY OF THE INSTRUMENT. THE LOCKING LATCH FRACTURE WAS CONSISTENT WITH A STRAIGHT TENSION OVERLOAD. (B)(4) CONCLUDED THAT THE FISSURE IS VERY LIKELY A CONSEQUENCE OF A FATIGUE FRACTURE DUE TO THE EXCESSIVE CONDITION OF USE, AS IT WAS ANALYZED IN THE NCR (B)(4) CLOSED IN 2010.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT THE HANDLE BROKE WHEN PLACING THE RASP IN THE HANDLE, DURING SURGERY. IT CANNOT HOLD THE RASP IN POSITION.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT THE HANDLE BROKE WHEN PLACING THE RASP IN THE HANDLE, DURING SURGERY. IT CANNOT HOLD THE RASP IN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85482 EXETER V40(TM). RASP HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH G1169201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other