BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL, AO T2 Ø3,5X130 MM

    MDR report key: 20046993 · Received August 23, 2024

    Report

    Report Number
    0009610622-2024-00810
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 25, 2024
    Report Date
    October 10, 2024
    Manufacturer
    STRYKER GMBH
    Product Code
    HWE
    UDI-DI
    04546540196644
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION - PLEASE REFER TO D4 LOT#, D9, THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. FURTHERMORE, REPORTED LOT NUMBER (KV52174) DOES NOT EXIST AND NO SIMILAR LOT NUMBER COULD BE FOUND. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    AS REPORTED : ''DURING SURGERY DRILL BIT BROKE AND REMAINED INSIDE THE PATIENT, THE SURGEON TRIED TO REMOVE IT AND COULD NOT, SO HE DECIDES TO LEAVE IT IN SITU. THE PATIENT NEEDS TO BE MONITORED BECAUSE PART OF THE DRILLS REMAINS INSIDE.''

    Description of Event or Problem · 0

    AS REPORTED : ''DURING SURGERY DRILL BIT BROKE AND REMAINED INSIDE THE PATIENT, THE SURGEON TRIED TO REMOVE IT AND COULD NOT, SO HE DECIDES TO LEAVE IT IN SITU. THE PATIENT NEEDS TO BE MONITORED BECAUSE PART OF THE DRILLS REMAINS INSIDE.''.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256995 DRILL, AO T2 Ø3,5X130 MM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER GMBH UNKNOWN 04546540196644

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O