BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 8274634 · Received January 24, 2019

    Report

    Report Number
    1020279-2019-00259
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Date of Event
    January 15, 2019
    Report Date
    February 8, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    UDI-DI
    03596010446114
    PMA / PMN Number
    K925573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL INCIDENT REPORT WAS SUBMITTED WITH INCORRECT MANUFACTURING SITE REGISTRATION NUMBER 1020279 (S+N MEMPHIS). THE CORRECT MANUFACTURING SITE REGISTRATION NUMBER IS 1219602(S+N MANSFIELD). CORRECTED DATA: G1 CONTACT INFORMATION.

    Additional Manufacturer Narrative · 0

    ONE 014771 T-FIX STERILE RCG DRILL PACK REPORTED ON. THE COMPLAINT STATED: ¿THE DRILL OF THE PRODUCT BROKE OFF IN THE BONE. DUE TO PRODUCT UNAVAILABILITY, THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DEFINITIVE CONCLUSIONS, ACCURATE INVESTIGATION AND EVALUATION WERE NOT FULLY POSSIBLE WITHOUT EVALUATION OF PHYSICAL PRODUCT. THEREFORE COMPLAINT COULD NOT BE ULTIMATELY CONFIRMED. IF OBJECTIVE EVIDENCE OR FURTHER RELEVANT INFORMATION BECOMES AVAILABLE TO ASSIST WITH EVALUATION, THE COMPLAINT WILL CERTAINLY BE REVISITED. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE ABILITY, SURGICAL ABILITY, IMPLANT LOCATION AND TISSUE CONDITION. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY THAT ARE UNRELATED TO MANUFACTURE INCLUDE: ENTANGLEMENT WITH ANOTHER INSTRUMENT OR DEVICE. DAMAGED OR USE OF OTHER THAN IFU RECOMMENDED PREP INSTRUMENT SIZE OR TYPES. UNEXPECTED BONE DENSITY/CONDITION. INCOMPATIBLE FORCE OR TORQUE APPLIED. THE SMITH AND NEPHEW ACUFEX T-FIX RCG DRILL PAC IS DESIGNED TO BE USED WITH THE ACUFEX T-FIX RCG GUIDE AND ACUFEX T-FIX 1.8 MM X 9 MM SUTURE BARS. THE DRILL AND SLEEVES ARE PROVIDED STERILE, FOR SINGLE PROCEDURE USE ONLY. IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. CAREFUL ATTENTION MUST BE PAID TO AVOID EXCESSIVE USE OF FORCE ON THE DRILL AND SLEEVES. PLACING EXTREME FORCES ON THE DRILL AND SLEEVES COULD RESULT IN DEVICE FAILURE. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LATERJET, WHILE USING THE DRILL AND SLEEVE TO DRILL THROUGH THE GLENOID BONE IN THE SHOULDER VIA THE GLENOID DRILLING GUIDE THE DRILL OF THE PRODUCT BROKE OF IN THE BONE. THE FLUTED ENDS WERE EXPOSED BUT THE DRILL WAS STILL PARTLY IN THE GLENOID. A GRASPER WAS USED TO PULL THE DRILL OUT OF THE BONE AND REMOVED FROM THE PATIENT. A NEW DRILL AND SLEEVE WAS OPENED AND THE PROCEDURE CONTINUED WITH ONLY A FEW MINUTES DELAY (3MINS). I RETRIEVED THE DRILL PARTS TO BE ANALYSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66538 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC. 014771 2017096 03596010446114

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR