BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX AB 6.5 MM RC

    MDR report key: 1810382 · Received August 20, 2010

    Report

    Report Number
    1219602-2010-00214
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 21, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT IS BEING COMPLETED TO ADD DEVICE EVALUATION. DEVICE WAS RECEIVED WITH THE DISTAL TIP OF THE ANCHOR BROKEN FREE AT THE EYELET LOCATION. THE TIP WAS NOT RETURNED. THE BREAK IS ACROSS 3 THREADS INDICATING SIDE LOADING FORCES BEING USED. WITHOUT KNOWLEDGE OF HOW THE SITE WAS PREPARED, NO FIRM CONCLUSIONS CAN BE MADE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4); THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4)

    Description of Event or Problem · 1

    AFTER THE PASSAGE OF THE INITIATOR (MALE) THE ANCHOR WAS PLACED IN THE RIGHT WAY, THE BONE WAS VERY GOOD. THE ANCHOR DID NOT HOLD UP THE RESISTANCE AND BROKE. THE ANCHOR BROKE WHILE IT WAS INTRODUCED INTO THE BONE. THE BACK-UP ANCHOR WAS PLACED IN THE SAME HOLE; HOWEVER, THE SURGEON SCREWED DEEPER BEFORE PLACING THE SECOND ANCHOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX AB 6.5 MM RC TWINFIX AB 6.5 SUTR ANCHR W/ULTRA MAI SMITH & NEPHEW ENDOSCOPY 72200779 50323449

    Patients

    Seq Age Sex Outcome Treatment
    1