BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7 X 23MM BIOSTEON WEDGE INTERFERENCE SCREW

    MDR report key: 5686353 · Received May 27, 2016

    Report

    Report Number
    0002936485-2016-00505
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    May 17, 2016
    Report Date
    May 18, 2016
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BIOCOMPOSITES IS THE LEGAL MANUFACTURER OF THE DEVICE. STRYKER ENDOSCOPY IS FILING ON BEHALF BIOCOMPOSITE BECAUSE IT WAS DETERMINED THAT THE EVENT REPORTED WAS A SERIOUS INJURY ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. BIOCOMPOSITES IS THE LEGAL MANUFACTURER OF THE DEVICE. STRYKER ENDOSCOPY IS FILING ON BEHALF BIOCOMPOSITE BECAUSE IT WAS DETERMINED THAT THE EVENT REPORTED WAS A SERIOUS INJURY ALLEGED FAILURE: SCREW BROKE. ACCORDING TO BIOCOMPOSITES, PROBABLE ROOT CAUSE: THE COMPOSITE SCREW FAILURE MODES REPORT AND POSSIBLE MODES OF FAILURE IDENTIFIED AS FOLLOWS: GRAFT/SCREW/TUNNEL NOT APPROPRIATELY SIZED; RESISTANCE TO INSERTION. THE ALLEGED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE INTO PIECES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE INTO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341136 7 X 23MM BIOSTEON WEDGE INTERFERENCE SCREW SCREW, FIXATION, BONE HWC STRYKER ENDOSCOPY-SAN JOSE 0915H118A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other