BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 2241593 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03275
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE REPORTED EVENT AS REPORTED WAS NOT DUPLICATED. THE HANDPIECE PASSED ALL STEPS OF THE QUALITY INSPECTION PROCEDURE AND DID NOT EXCEED THE MAXIMUM ALLOWED TEMPERATURE. THE PAN HEAD MACHINE SCREW WAS LOOSE ON THE LINEAR BEARING ASSEMBLY, WHICH COULD EVENTUALLY LEAD TO OVERHEATING, HOWEVER THIS WAS NOT OBSERVED. THE DHR REVIEW INDICATED THE DEVICE PASSED ALL TESTING AND INSPECTIONS AS REQUIRED AT THE TIME OF MFR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING AN UNK PROCEDURE. THE PROCEDURE WAS COMPLETED W/THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO RECIPROCATING SAW ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK