BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRSPR PREDATOR TISSUE(SEE 72201180)

    MDR report key: 11858029 · Received May 20, 2021

    Report

    Report Number
    1219602-2021-01183
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 30, 2021
    Report Date
    June 24, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LDQ
    UDI-DI
    03596010474483
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL SHOULDER PROCEDURE, WHEN THE ANCHOR WAS PLACED THROUGH THE PORTAL, THE ANCHOR CAME LOOSE FROM THE CABLE, BEING NECESSARY TO REMOVE IT WITH A GRASPER, WHEN TRYING TO ATTACH IT WITH THE GRASPER IT BROKE OFF. THE PARTS WERE REMOVED FROM THE PATIENT. A CHANGE IN THE SURGICAL TECHNIQUE WAS PERFORMED. A DELAY GREATER THAN 30 MINUTES WAS REPORTED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755875 GRSPR PREDATOR TISSUE(SEE 72201180) DEVICE, GENERAL MEDICAL LDQ SMITH & NEPHEW, INC. 994 03596010474483

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR