BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT STRAP ANKLE DSTRCTR STRL(6)

    MDR report key: 11100324 · Received December 31, 2020

    Report

    Report Number
    1219602-2020-02212
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 9, 2020
    Report Date
    March 12, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KQZ
    UDI-DI
    03596010095329
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3,H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGES FOUND THIN BLUE FIBERS IN THE PACKAGING THAT MATCHED THE COLORING AND THREAD SIZE OF THE NYLON STRAP. THE BATCH NUMBER OF THE PACKAGING THIS WAS FOUND IN WAS NOT FOUND. A VISUAL INSPECTION REVEALED THAT THE PACKAGE HAD NOT BEEN OPENED, AND THE SEALS DID NOT CONTAIN ANY VOIDS OR PROBLEMS. ON THIS PACKAGE, HOWEVER, THE TOP FILM HAD BEEN SLICED THROUGH. IT IS ASSUMED THAT THIS OCCURRED IN TRANSIT TO THE EVALUATION CENTER, AS A SIMILAR SLICE WAS NOTED ON THE PAPER COVERING THE PACKAGE AND THE EXTERIOR ZIP BAG. THERE WAS A SMALL BLUE FIBER IN THE PACKAGING THE MATCHED THE COLOR AND SHEEN OF THE NYLON STRAP. A REVIEW OF THE DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF THE DRAWING FOUND THAT PACKAGES MUST BE FREE OF PARTICULATES. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH TRANSPORT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE EXCESS RUBBING OR JOSTLING IN TRANSPORT, TOUGH SHIPPING AND HANDLING, OR AN IMPACT EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY IT WAS FOUND A FOREIGN MATTER INSIDE THE STERILE ANKLE DISTRACTOR FOOT STRAPS PACKAGE. NO PATIENT INJURIES OR DELAY REPORTED. UNKNOWN IF THERE WAS A BACK-UP DEVICE TO COMPLETE THE SURGERY. 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
    1564590 FOOT STRAP ANKLE DSTRCTR STRL(6) COMPONENT, TRACTION, NON-INVASIVE KQZ SMITH & NEPHEW, INC. 014407 2056656 03596010095329

    Patients

    Seq Age Sex Outcome Treatment
    1