BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX

    MDR report key: 3231922 · Received July 17, 2013

    Report

    Report Number
    1219602-2013-00163
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE ANCHOR IS BROKEN AT THE DISTAL TIP. A REQUEST WAS MADE TO INQUIRE AS TO SITE PREPARATION AND THE PATIENT¿S BONE QUALITY; HOWEVER, TO DATE NO INFORMATION HAS BEEN RECEIVED. PER THE INSTRUCTIONS FOR USE 10600675 REV. B, ¿USE THE APPROPRIATE SMITH & NEPHEW AWL-DILATOR TO PREPARE THE INSERTION SITE, FOR GENERAL USE, REF 72202634, 5.5/6.5 AWL-DILATOR. WHEN A LARGER HOLE IS REQUIRED, AS IN THE CASE WITH HARD BONE, USE A DRILL TO CREATE A PILOT HOLE FOR THE ANCHOR, THEN INSERT THE AWL-DILATOR TO BETTER PREPARE THE BONE FOR THE ANCHOR, REF 72201707, DRILL, 4.5 MM SPADE TIP. 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.¿ A REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGICAL PROCEDURE, WHILE INSERTING THE TWINFIX ULTRA HA ANCHOR, THE TIP OF THE ANCHOR BROKE UPON INSERTION. IT WAS REPORTED THAT ALL PIECES OF THE BROKEN ANCHOR WERE REMOVED FROM THE PATIENT. A BACK UP DEVICE WAS ON HAND TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR SIGNIFICANT TIME DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330703 TWINFIX TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK MAI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 50429832

    Patients

    Seq Age Sex Outcome Treatment
    1