BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2042113 · Received April 6, 2011

    Report

    Report Number
    1030489-2011-00379
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRIVER WAS RETURNED FOR EVALUATION. VISUAL AND OPTICAL EXAMINATION REVEALS APPROXIMATELY ~3MM OF TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT, BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. 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 LUMBAR FUSION. IT WAS REPORTED THAT DURING INSERTION OF A BONE SCREW THE TIP OF THE DRIVER BROKE OFF IN THE SCREW. THE TIP WAS REMOVED WITH SUCTION. IT WAS DECIDED THAT THE PLACEMENT OF THE SCREW WAS SUFFICIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDIC, INC. NA JM00611

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW