BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER

    MDR report key: 554012 · Received September 13, 2004

    Report

    Report Number
    MW1033227
    Event Type
    Other
    Date Received
    September 13, 2004
    Date of Event
    September 7, 2004
    Report Date
    September 13, 2004
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    HWC
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 4.0MM, 16MM SCREW IN STRYKER SMALL FRAGMENT SET BROKE COMPLETELY AT HEAD OF SCREW, WITHOUT RESISTANCE, DURING PROCEDURE. MD WAS UNABLE TO RETRIEVE THE SCREW FRAGMENT. THE NEXT DAY, DURING A DIFFERENT CASE, ANOTHER SCREW OF EXACT TYPE & MFG, STARTED TO BEND DURING PROCEDURE, MD WAS ABLE TO RETRIEVE WITHOUT INCIDENT.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/13/05: THE SPECIFIC LOT NUMBER OF THIS DEVICE COULD NOT BE DETERMINED. A MEDWATCH REPORT WAS NOT SUBMITTED IN RESPONSE TO THIS EVENT. THERE IS NO EVIDENCE POSITIVELY IDENTIFYING THIS AS A REPORTABLE EVENT. THE PHOTOS MFR RECEIVED INDICATE THAT THE HEAD OF THE SCREW WAS RETRIEVED. THE BOTTOM PORTION OF THE SCREW REMAINED IN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER 16MM SCREW, SMALL FRAGMENT SET HWC STRYKER ORTHOPAEDICS 345516 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other