BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 12010336 · Received June 16, 2021

    Report

    Report Number
    1219602-2021-01374
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 25, 2021
    Report Date
    October 5, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    UDI-DI
    03596010446114
    PMA / PMN Number
    K925573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. 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 · 0

    THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. SNARE WIRE AND CROSS BAR WERE RETURNED WITH DEVICE. THE ANCHOR IS DETACHED AND RETURNED BROKEN. DUE TO THE ANCHOR DAMAGE FUNCTIONAL TESTING COULD NOT BE CONDUCTED. 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 DRAWING FOUND THAT THE STRENGTH AND MATERIAL OF THE ANCHOR IS VERIFIED. BASED ON THE CONDITION OF THE PRODUCT MATERIAL FOUND DURING VISUAL INSPECTION IT WAS DETERMINED THE DEVICE DAMAGE WAS CAUSED BY THE APPLICATION OF IMPROPER/EXCESSIVE FORCE. ADDITIONAL MATERIAL TESTING IS NOT REQUIRED. A CLINICAL REVIEW STATES PER THE COMPLAINT DETAILS, THIS REPRESENTS A PROCEDURE COMPLICATION AND DOES NOT REPRESENT A DEVICE MALFUNCTION. BASED ON THE INFORMATION PROVIDED, THIS EVENT RESULTED IN DAMAGE TO THE PATIENT¿S BONES AND SOFT TISSUES DURING THE BREAKAGE AND REMOVAL OF THE BROKEN DEBRIS, SUBSEQUENTLY, IMPACTING THE LENGTH OF THE INTERVENTION. THE FUTURE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE DETERMINED. SINCE IT WAS REPORTED, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL RELEVANT MEDICAL INFORMATION BE PROVIDED, THIS COMPLAINT WILL BE RE-ASSESSED. THE COMPLAINT WAS CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: (1) TISSUE THICKNESS. (2) EXCESSIVE FORCE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC BONE BLOCK SURGERY, WHEN TRYING TO DRILL THE ¿RIGHT¿ BULLET FROM THE JIG, RESISTANCE WAS FELT WHEN DRILLING. IT WAS NOTICED THAT A SMALL FRAGMENT OF THE DRILL SLEEVE WAS STUCK IN THE BULLET. THE BULLET WAS REMOVED AND REMNANT OF THE SLEEVE REMOVED FROM THE BULLET. A SECOND PACK WAS OPENED AND USED TO CHECK IF THE NEW SLEEVE WOULD PASS SAFELY THROUGH THE RIGHT BULLET, THE RIGHT TUNNEL WAS SUCCESSFULLY DRILLED WITH THE BACKUP PACK. A DELAY OF 3 MINUTES WAS REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904718 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC. 014771 50890789 03596010446114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention