BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LOCKING SCREW

    MDR report key: 16400514 · Received February 17, 2023

    Report

    Report Number
    0009610622-2023-00049
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    May 11, 2022
    Report Date
    May 7, 2023
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.DEVICE DISPOSITION UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD BE CONFIRMED, FROM THE PROVIDED X-RAYS FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED DEVICE WAS NOT RETURNED, AND THE LOT NUMBER WAS NOT COMMUNICATED. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. A FEW X-RAYS WERE PROVIDED WHICH WERE PRESENTED TO OUR HEALTH CARE PROFESSIONAL FOR EVALUATION, AND A QUESTION ABOUT THE MOST LIKELY REASON FOR THIS EVENT WAS ASKED, TO WHICH THE MEDICAL EXPERT REPLIED: ¿THERE IS VERY LIMITED INFORMATION FOR ME TO WORK WITH HERE. NON-UNION IS CONFIRMED FOR THIS CASE IN THE ATTACHED X-RAY SHOTS. AS YOU MAY BE AWARE, NON-UNION IS OFTEN MULTI-FACTORIAL. ONE OF THE FACTORS IN THIS CASE MAY HAVE BEEN INSTABILITY OF THE CONSTRUCT FOR THIS LOW FEMUR FRACTURE. THE CONTINUOUS MOVEMENT IN THE NAIL, MIGHT HAVE CAUSED THE NON-UNION AND BREAKAGE OF THE SCREW.¿. [ORIGINAL STATEMENT(S)]. 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. IF THE DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A TWITTER POST WHICH WAS PUBLISHED BY THE DR. Q IN MAY 2022. THE REPORT IS ABOUT A FEMORAL SHAFT FRACTURE THAT ENDED IN NON-UNION, WHICH IS ASSOCIATED WITH A STRYKER GAMMA 3 NAIL. THE POST CAN BE FOUND AT HTTPS://TWITTER.COM/AQUEIPOT/STATUS/1524466992899629056. IT WAS REPORTED THAT THERE WAS A NON-UNION 12 MONTHS AFTER IMPLANTATION. THE PATIENT HAD REPORTED PAIN, SO X-RAYS WERE TAKEN. ADDITIONALLY 2 SCREWS HAD BEEN BROKEN. THE NAIL AND SCREWS WERE REVISED AND THE NON-UNION HEALED AFTER 3 MONTHS.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A TWITTER POST WHICH WAS PUBLISHED BY THE DR. (B)(6) IN MAY 2022. THE REPORT IS ABOUT A FEMORAL SHAFT FRACTURE THAT ENDED IN NON-UNION, WHICH IS ASSOCIATED WITH A STRYKER GAMMA 3 NAIL. THE POST CAN BE FOUND AT HTTPS://TWITTER.COM/AQUEIPOT/STATUS/1524466992899629056. IT WAS REPORTED THAT THERE WAS A NON-UNION 12 MONTHS AFTER IMPLANTATION. THE PATIENT HAD REPORTED PAIN, SO X-RAYS WERE TAKEN. ADDITIONALLY 2 SCREWS HAD BEEN BROKEN. THE NAIL AND SCREWS WERE REVISED AND THE NON-UNION HEALED AFTER 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359981 UNKNOWN LOCKING SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention