BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSITOMIC STERILE PIN PACK

    MDR report key: 12550574 · Received September 29, 2021

    Report

    Report Number
    0002936485-2021-00520
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    August 3, 2021
    Report Date
    November 10, 2021
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RECEIVED IN-HOUSE AT STRYKER ENDOSCOPY. TAG CANNOT PROVIDE THE FULLY DETAILED INVESTIGATION REPORT TO STRYKER AS THE DEVICE WAS NOT RETURNED. IN THE EVENT THAT THE DEVICE IS RETURNED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: REAMER BROKE ACCORDING TO TAG: SINCE WE HAVE NOT RECEIVED THE DEVICE WE CAN SUGGEST SEVERAL REASONS FOR BREAKAGE: 1. THE MOST LIKELY CAUSE IS THE USE OF EXCESSIVE FORCE THAT CAN LEAD TO THE BREAKAGE OF THE FLEXIBLE PIN. 2. SEVERE BENDING CAN RESULT IN PIN BREAKAGE. 3. THE FLEXIBLE GUIDE PIN MAY BREAK IF THE CURVED SECTION OF THE PIN IS EXPOSED TO A DRY ENVIRONMENT WHILE DRILLING. 4. THE FLEXIBLE GUIDE PIN FATIGUES DURING DRILLING AND IS AT RISK OF BREAKAGE IF USED IN MORE THAN ONE SURGICAL CASE. MANUFACTURE DATE IS NOT KNOWN. H3 OTHER TEXT : 81.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE AND REMAINED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. THE GTIN AND PRODUCT CODE ARE NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. FILING ON BEHALF OF OEM - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF THE DEVICE BROKE AND REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448584 VERSITOMIC STERILE PIN PACK UNKNOWN GFG STRYKER ENDOSCOPY-SAN JOSE 19P01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other