BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 8336732 · Received February 13, 2019

    Report

    Report Number
    1219602-2019-00193
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 15, 2019
    Report Date
    March 17, 2019
    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 · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    ONE (B)(4) T-FIX STERILE RCG DRILL PACK REPORTED ON. 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. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. FAILURES ARE MONITORED BY SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE 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). ALL THE DRILL PARTS WERE REMOVED. A BACK UP DEVICE WAS AVAILABLE AND NO PATIENT INJURIES OR SIGNIFICANT DELAY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127256 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC. 03596010446114

    Patients

    Seq Age Sex Outcome Treatment
    1