BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGETING SLEEVE GAMMA3 180

    MDR report key: 2748300 · Received September 6, 2012

    Report

    Report Number
    9610622-2012-00397
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Date of Event
    August 20, 2012
    Report Date
    August 20, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD'L DEVICES: TARGETING SLEEVE GAMMA3 180, 1320-0118 LOT UNK. TARGET DEVICE GAMMA3 300X160MM, 1320-0100 LOT UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING SURGERY (AFTER NAIL WAS INSERTED AND WHEN SURGEON WAS MAKING INCISION FOR LAG SCREW), DR INFORMED ME THAT HE WAS UNABLE TO LOCK THE TARGETER WHEN THE TISSUE PROTECTION SLEEVE FOR THE LAG SCREW WAS INSERTED AT THE 125 DEGREE CCD. WE PROCEEDED TO FINISH THE SURGERY WITHOUT LOCKING THE TISSUE PROTECTION SLEEVE FOR THE LAG SCREW. NO ADVERSE CONSEQUENCES TO THE PT AND THE DELAY WAS LESS THAN THIRTY SECONDS. AFTER THE SURGERY, REP NOTED THAT KNOB COULD LOCK WHEN THE TISSUE PROTECTION SLEEVE WAS NOT INSERTED; HOWEVER, NOT WITH THE SLEEVE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGETING SLEEVE GAMMA3 180 INSTRUMENT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other