BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 19094127 · Received April 11, 2024

    Report

    Report Number
    1219602-2024-00772
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 19, 2024
    Report Date
    May 9, 2024
    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
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H10 H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE 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 RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES THAT PHOTOS OF THE DEVICE PACKAGING AND THE DEVICE WERE PROVIDED FOR REVIEW AND CONFIRM THE BREAKAGE, HOWEVER THEY DO NOT INDICATE THE ROOT CAUSE FOR THE BREAKAGE. BASED ON THE LIMITED INFORMATION PROVIDED THE CLINICAL ROOT CAUSE OF THE REPORTED EVENTS CANNOT BE DETERMINED AND WE ARE CURRENTLY UNABLE TO RULE OUT A PROCEDURAL VARIANCE AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT, WHICH DOES NOT REPRESENT A DEVICE MALFUNCTION. NO FURTHER RISK TO THE PATIENT IS ANTICIPATED AS A RESULT OF THE ADDITIONAL BONE HOLE. SINCE NO FURTHER HARM IS ANTICIPATED NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESSIVE FORCE ON THE DEVICE, EXCESSIVE TORQUE ON THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OFF-AXIS INSERTION, IMPROPER PREPARATION OF THE INSERTION SITE, OR AN INADVERTENT IMPACT EVENT. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. INTERNAL COMPLAINT REFERENCE (B)(4). H11 H6: F CODES UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MINI-OPEN LATERJET PROCEDURE, THE SLEEVE OF THE 2.0MM T-FIX DRILL BROKE WHEN DRILLING THE INFERIOR HOLE USING WITH A GLENOID GUIDE. THE METAL SLEEVE BROKE OFF ABOUT 1 INCH INSIDE THE GLENOID. THE PIECES WERE REMOVED FROM THE PATIENT. THERE WAS A DELAY IN THE LESS THAN 30 MINUTES AND IT WAS COMPLETED WITH A COMPETITOR DEVICE ( SMALL AND LARGE FRAG SCREW SET, SYNTHES) USING AN ADDITIONAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808813 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC. 2133959 03596010446114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other