BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2402325 · Received January 6, 2012

    Report

    Report Number
    1030489-2012-00021
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    October 25, 2011
    Report Date
    December 8, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. MACROSCOPIC EXAMINATION CONFIRMS TIP OF PROBE SEVERELY TWISTED, WITH APPROX. 15MM OF THE TIP BROKEN OFF. INSPECTION OF SHAFT DIAMETER AND MATERIAL HARDNESS CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS REVEALED A QUASI-BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD DURING USAGE. THE TIP JUST BELOW THE FRACTURE IS SEVERELY PLASTICALLY DEFORMED, ALSO CONSISTENT WITH TORSIONAL OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-S1. IT WAS REPORTED THAT THE PROBE WAS BEING INSERTED IN THE PEDICLE AND BECOME LODGED. DURING REMOVAL OF THE PROBE THE TIP BROKE OFF IN THE PEDICLE. THE TIP WAS REMOVED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PROBE HXB WARSAW ORTHOPEDICS NA SW10G204

    Patients

    Seq Age Sex Outcome Treatment
    1