BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6" 17G CURVED DEK KIT

    MDR report key: 5034297 · Received August 27, 2015

    Report

    Report Number
    0001811755-2015-03127
    Event Type
    Injury
    Date Received
    August 27, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 14, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K032473
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE ROOT CAUSE APPEARS TO BE RELATED TO ROUGH HANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE PROCEDURE AT THE HEALTHCARE FACILITY, THE TIP OF THE AUGER WAS NOTICED TO BE MISSING WHEN THE AUGER WAS REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT ON THE FLUOROSCOPY SCAN, IT COULD NOT BE DETERMINED IF THE TIP WAS IN THE PATIENT, AND THAT FURTHER SCANS WERE PLANNED IN ORDER TO DETERMINE IF THE TIP REMAINED IN THE PATIENT, AND THAT A SPINE SPECIALIST WOULD BE CONSULTED FOR THE REMOVAL OF THE TIP FROM THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A 30 MINUTE DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE PROCEDURE AT THE HEALTHCARE FACILITY, THE TIP OF THE AUGER WAS NOTICED TO BE MISSING WHEN THE AUGER WAS REMOVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT ON THE FLUOROSCOPY SCAN IT COULD NOT BE DETERMINED IF THE TIP WAS IN THE PATIENT, AND THAT FURTHER SCANS WERE PLANNED IN ORDER TO DETERMINE IF THE TIP REMAINED IN THE PATIENT, AND THAT A SPINE SPECIALIST WOULD BE CONSULTED FOR THE REMOVAL OF THE TIP FROM THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A 30 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567152 6" 17G CURVED DEK KIT ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO 15134012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention