BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCR SFTSLK 2.0 PKG.8X20 STER

    MDR report key: 9848772 · Received March 18, 2020

    Report

    Report Number
    1219602-2020-00535
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    February 5, 2020
    Report Date
    April 10, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    UDI-DI
    03596010375391
    PMA / PMN Number
    K921481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7207259 SOFT SILK 8X20MM SCREW USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. DUE TO PRODUCT UNAVAILABILITY, EVALUATION WAS LIMITED. IF FURTHER INFORMATION, BECOMES AVAILABLE, THE COMPLAINT MAY BE REVISITED. PER IFU 1060403: IT IS THE SURGEON¿S RESPONSIBILITY TO BE FAMILIAR WITH THE APPROPRIATE SURGICAL TECHNIQUES PRIOR TO USE OF THIS DEVICE. READ THESE INSTRUCTIONS COMPLETELY PRIOR TO USE.¿ THERE WAS COMPROMISED BONE QUALITY REPORTED. COMPLAINT HISTORY REVIEW INDICATED NO SIMILAR ALLEGATIONS FOR THE LOT NUMBER REPORTED. BATCH REVIEW DID NOT INDICATE A CONDITION, PRODUCT OR PROCEDURE FAILURE THAT SUPPORTED THE ALLEGATION. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE WAS NOT CONFIRMED. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H11: G4: CORRECT AWARE DATE IS (B)(6) 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ACL REVISION SURGERY, A NEW 8X20MM SOFTSILK SCREW WAS USED, BUT THE TENDON WAS LOOSE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP 8X10MM SOFTSILK SCREW INTO AN ADDITIONAL BONE HOLE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310368 SCR SFTSLK 2.0 PKG.8X20 STER SCREW, FIXATION, BONE HWC SMITH & NEPHEW, INC. 7207259 50797286 03596010375391

    Patients

    Seq Age Sex Outcome Treatment
    1