BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE DRL 10MM

    MDR report key: 11974160 · Received June 10, 2021

    Report

    Report Number
    1219602-2021-01331
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 21, 2021
    Report Date
    July 16, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GFG
    UDI-DI
    00885554037753
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: PART OF THE DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION FOUND THAT THE RETROGRADE DRILL WAS RETURNED WITHOUT THE GUIDEWIRE OR SUTURE GUIDE. THE RETROGRADE DRILL WAS NOT DEFORMED OR DENTED. A FUNCTIONAL EVALUATION FOUND THAT THE RETROGRADE DRILL FUNCTIONED AS EXPECTED. 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 COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. 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.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TRUNAV RETROGRADE DRILL'S WIRE AT THE END OF THE DRILL WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868968 RETROGRADE DRL 10MM BIT, SURGICAL GFG SMITH & NEPHEW, INC. 72204046 4921541 00885554037753

    Patients

    Seq Age Sex Outcome Treatment
    1