BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALICOIL KNOTLESS PK ST

    MDR report key: 12573092 · Received October 4, 2021

    Report

    Report Number
    1219602-2021-02200
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 10, 2021
    Report Date
    November 11, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    00885556767351
    PMA / PMN Number
    K193558
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. 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 REVIEW OF THE MATERIAL SPECIFICATIONS FOUND THERE ARE REQUIREMENTS FOR CONFORMANCE AND A CERTIFICATE OF MATERIAL ANALYSIS IS REQUIRED. SMITH AND NEPHEW DID NOT RECEIVE ADEQUATE CLINICAL DOCUMENTATION OR THE DEVICE FOR INCLUSION IN THIS MEDICAL INVESTIGATION. THEREFORE, A THOROUGH MEDICAL INVESTIGATION CANNOT BE RENDERED NOR CAN A CLINICAL ROOT CAUSE OF THE REPORTED FAILURE BE DETERMINED. PER SUBSEQUENT EMAIL, THE RESIDUAL MATERIAL WAS REMOVED FROM INSIDE OF THE PATIENT. HOWEVER, IT IS UNKNOWN IF THE IFU FOR THE HEALICOIL WAS ADHERED TO. THE IFU FOR THE 1060355-M HEALICOIL KNOTLESS PK 5 IMPLANT WARNS: ¿IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE.¿ BASED ON THE INFORMATION PROVIDED, THE REPAIR WAS WEAKENED, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WAS A 45-MINUTE SURGICAL DELAY REPORTED. THEREFORE, THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE DETERMINED. SHOULD ANY ADDITIONAL MEDICALLY RELEVANT DOCUMENTATION BE PROVIDED, THIS COMPLAINT WOULD BE RE-ASSESSED. 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 CASE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIGAMENT REPAIR, THE HEALICOIL KNOTLESS PK IMPLANT WAS FRACTURED AT THE END OF THE PLACEMENT. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE REPAIR WAS WEAKENED AND THE DURATION OF THE OPERATION WAS INCREASED BY ABOUT 45 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470401 HEALICOIL KNOTLESS PK ST FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50917426 00885556767351

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention