BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1971409 · Received January 27, 2011

    Report

    Report Number
    1030489-2011-00075
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. APPROXIMATELY ~3MM OF TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. THE BROKEN OF PORTION WAS NOT RETURNED FOR ANALYSIS. SHAFT HARDNESS CONFIRMS HARDNESS IS WITHIN PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT, BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. SHAFT ASSEMBLY PINS ALSO BROKEN, CONSISTENT WITH EXCESSIVE FORCE. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR REVISION SURGERY AT L2-S1 TO TREAT AN ADJACENT LEVEL FROM ORIGINAL SURGERY. AFTER REMOVAL OF THE ORIGINAL CONSTRUCT, MANUFACTURED BY ANOTHER COMPANY, THE PATIENT UNDERWENT RE-INSTRUMENTATION WITH SCREWS. WHILE IMPLANTING A SCREW AT THE RIGHT SIDE OF THE L4 PEDICLE THE TIP OF THE SCREWDRIVER BROKE. THE SURGEON DID NOT FEEL COMFORTABLE ADVANCING THE SCREW ANY FARTHER SO IT REMAINED A FEW MILLIMETERS HIGHER THAN THE ADJACENT SCREWS. THE TIP OF THE DRIVER WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA RS10J023

    Patients

    Seq Age Sex Outcome Treatment
    1