BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N

    MDR report key: 10434895 · Received August 20, 2020

    Report

    Report Number
    1219602-2020-01291
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    July 30, 2020
    Report Date
    September 30, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    03596010532190
    PMA / PMN Number
    K972326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 7210707 TWINFIX TI 3.5 PRELOADED SUTURE ANCHOR DEVICE WAS USED IN TREATMENT BUT WAS NOT RETURNED FOR EVALUATION. DUE TO UNAVAILABILITY, EVALUATION WAS LIMITED. IF INFORMATION AVAILABLE TO ASSIST WITH EVALUATION, THE COMPLAINT MAY BE REVISITED. FACTORS THAT MAY AFFECT DEVICE PERFORMANCE INCLUDE: DEVICE STORAGE, DEVICE ABILITY, SURGICAL ABILITY, PROCEDURE LOCATION AND TISSUE CONDITION. INFLUENCES THAT COULD COMPROMISE PRODUCT PERFORMANCE OR INTEGRITY INCLUDE: UNEXPECTED BONE CONDITION/DENSITY. ALTERNATE PREP METHOD OR INSTRUMENTS USED. ALTERNATE INSERTION TECHNIQUE USED. INCOMPLETE ANCHOR INSERTION. LOSS OF OR LACK OF AXIAL ALIGNMENT. INSTRUCTIONS FOR USE ARE QUITE SPECIFIC FOR THIS DEVICE. PER IFU 1061182: ¿CAUTION: IT IS THE RESPONSIBILITY OF THE SURGEON TO DETERMINE THE PATIENT¿S BONE CONDITION, APPROPRIATELY PREPARE THE INSERTION SITE, AND DETERMINE THE SUITABILITY OF THE IMPLANT FOR THE PROCEDURE. PROPER SITE PREP INCLUDES PRE-DRILLING WHICH IS ESSENTIAL FOR SUCCESSFUL USE OF THE DEVICE. THE APPROPRIATE SMITH AND NEPHEW DRILL BIT AND DRILL GUIDE ARE EACH SOLD SEPARATELY. 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. INSTRUCTIONS FOR USE (IFU) CONTAINS RECOMMENDATIONS AND PRECAUTIONARY STATEMENTS FOR PROPER USE OF PRODUCT. RISK MANAGEMENT FILES CONTAIN THE REPORTED FAILURE. PRODUCT MET SPECIFICATIONS UPON RELEASE TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TENDON REPAIR AFTER EXCISION ACCESSORY NAVICULAR, 2 OF THE 4 NEEDLES CAME OFF THE SUTURES. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR FURTHER COMPLICATIONS 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
    897701 TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 7210707 2048109 03596010532190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention