BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSTEON INTRALINE

    MDR report key: 10565786 · Received September 22, 2020

    Report

    Report Number
    9617083-2020-00001
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 22, 2020
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    LOE
    UDI-DI
    15060155711185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE SHIPPED TO STRYKER IN (B)(6) WITH MISSING CONTRAINDICATION SECTION IN THE INSTRUCTIONS FOR USE. COMMERCIAL NAME/BRAND: BIOSTEON INTRALINE 5.5MM ANCHOR, NEEDLES, TWO #2 FORCE FIBER. BIOSTEON INTRALINE 5.5MM ANCHOR, THREE #2 FORCE FIBER. BIOSTEON INTRALINE 6.5MM ANCHOR, THREE #2 FORCE FIBER. LOT/BATCH NUMBERS: BI200709, BI200710. MODEL NUMBERS: 3910-200-082 - QUANTITY SHIPPED: X18 PACKS - TOTAL OF X90 DEVICES, X5 PER PACK. 3910-200-083 - QUANTITY SHIPPED X6 PACKS - TOTAL OF X30 DEVICES, X5 PER PACK 3910-200-086 - QUANTITY SHIPPED X10 PACKS - TOTAL OF X50 DEVICES, X5 PER PACK. RECALL REASON: INSTRUCTIONS FOR USE (IFU) ARE MISSING CONTRAINDICATIONS SECTION. PLANNED ACTION: PRODUCTS AFFECTED TO BE RETURNED TO BIOCOMPOSITES LTD. FOR REWORKING TO ADD AMENDED INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    BIOSTEON INTRALINE DEVICES LEFT THE MANUFACTURING SITE WITH KEY INFORMATION MISSING FROM THE INSTRUCTIONS FOR USE. CONTRAINDICATIONS WERE MISSING FROM LATEST REVISION (REVISION E) DURING UPDATE OF THE INSTRUCTIONS FOR USE, THE CONTRAINDICATIONS SECTION WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035607 BIOSTEON INTRALINE SUTURE ANCHOR LOE BIOCOMPOSITES LTD. 3910-200-083 BS200709/710 15060155711185

    Patients

    Seq Age Sex Outcome Treatment
    1