BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-BLADE INSERTER

    MDR report key: 1813213 · Received August 18, 2010

    Report

    Report Number
    9610622-2010-00339
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 27, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED U-BLADE INSERTER CONFORMS TO SPECIFICATION. A FUNCTIONAL DEVIATION OF THE INSERTER COULD NOT BE VERIFIED DURING FUNCTIONAL TEST (UNDER DRY CONDITIONS). NEVERTHELESS, THE ALLEGED EVENT MAY BE LINKED TO THE DESIGN OF THE U-BLADE INSERTER. REVIEW OF DEVICE HISTORY RECORD (DHR) / REVIEW OF INSPECTION RECORDS. A REVIEW OF THE DHR / INSPECTION RECORDS FOR THE U-BLADE INSERTER (LOT CODE K898160) REVEALED NO DISCREPANCIES. MEANWHILE, THE DESIGN OF THE INSERTER HAS BEEN CHANGED IN ORDER TO OPTIMIZE THE CLAMPING FORCE ESPECIALLY UNDER WET CONDITIONS.

    Description of Event or Problem · 1

    THE CUSTOMER RETURNED THE U-BLADE INSERTER AND STATES IN HIS ACCOMPANYING QUESTIONNAIRE THAT THE DEVICE DID NOT LOCK ONTO THE ROD WHEN THE TRIGGER WAS PRESSED. THE SURGERY WAS FINISHED WITH AN EXCHANGE INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U-BLADE INSERTER INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K898160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other