BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN DOUBLE ENDOBUTTON DEV

    MDR report key: 12465693 · Received September 13, 2021

    Report

    Report Number
    1219602-2021-01974
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    March 7, 2000
    Report Date
    January 3, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    PMA / PMN Number
    K994202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE A FAILURE OF A CONCOMITANT DEVICE. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. 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 THERE WAS INSUFFICIENT INFORMATION TO TIE THE REPORTED COMPLAINT TO SPECIFIC LINE ITEMS WITHIN THE RISK FILE. OUR CLINICAL INVESTIGATION CONCLUDED: WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED. IN ADDITION, THE PHYSICIAN REFERENCED IN THE ABSTRACT PROVIDED AN ANALYSIS OF ALL OF THE ATTACHED IMAGES. THEREFORE, NO FURTHER INTERPRETATION OF THE ATTACHED IMAGES ARE REQUIRED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. 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

    (B)(4). ZYSK SP, KRÜGER A, BAUR A, VEIHELMANN A, REFIOR HJ. TRIPLED SEMITENDINOSUS ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH ENDOBUTTON FIXATION: A 2-3-YEAR FOLLOW-UP STUDY OF 35 PATIENTS. ACTA ORTHOP SCAND. 2000 AUG;71(4):381-6. DOI: 10.1080/000164700317393385. PMID: 11028887.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW "TRIPLED SEMITENDINOSUS ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH ENDOBUTTON FIXATION: A 2-3-YEAR FOLLOW-UP STUDY OF 35 PATIENTS", AFTER SURGERY USING SUTURE WASHER, 2 PATIENTS HAD LIMITED MOTION REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360718 UNKN DOUBLE ENDOBUTTON DEV SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention