BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING ARM T2 PROX. HUM.

    MDR report key: 2651057 · Received June 27, 2012

    Report

    Report Number
    9610622-2012-00289
    Event Type
    Malfunction
    Date Received
    June 27, 2012
    Date of Event
    June 15, 2012
    Report Date
    June 18, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: PROXIMAL HUMERAL NAIL, CANNULATED, LEFT T2 PROX HUM 8 X 150 MM: 1832-1035S, LOT # K921877; NAIL ADAPTER T2 PROX. HUM: 1806-2025, LOT # UNK; NAIL HOLDING SCREW, HUMERUS T2 HUMERUS 10 MM: 1806-0163, LOT # UNK; NUT 52 PROX HUM: 1806-2030, LOT # UNK; TISSUE PROTECTION SLEEVE, SHORT 52 TIBIA 9 MM: 1806-0180, LOT # UNK; DRILL SLEEVE, SHORT 52 TIBIA 5 MM: 1806-0210, LOT # UNK.

    Description of Event or Problem · 1

    ON (B)(6) 2012, T2PH SHORT NAIL OPERATION WAS PERFORMED. BEFORE INSERTION OF THE NAIL INTO BONE, SURGEON CONFIRMED ASSEMBLY OF THE DEVICE. HE INSERTED SCREWS TO PROXIMAL HOLES AND DISTAL UPPER HOLE WITHOUT PROBLEM. HE TRIED TO INSERT A SCREW TO DISTAL LOWER HOLE, BUT THE SCREW COULD NOT BE INSERTED NORMALLY. HE CONFIRMED BY IMAGE INTENSIFIER AND NOTICED THAT THE DRILL DID NOT PASS ALONG THE HOLE. THEN HE REMOVED THE DEVICE, DID THE DRILLING WITH THE RADIOLUCENT DRILL WHICH WAS HOSPITAL OWNED AND INSERTED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING ARM T2 PROX. HUM. INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR