BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX ULTRA - TI

    MDR report key: 2754737 · Received September 21, 2012

    Report

    Report Number
    1219602-2012-00252
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    August 23, 2012
    Report Date
    August 23, 2012
    Manufacturer
    SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS INITIALLY RECEIVED ON (B)(4) 2012; HOWEVER INVESTIGATION WAS ONGOING AT THAT TIME. DEVICE INVESTIGATION WAS COMPLETED ON (B)(4) 2012 AND THEREFORE THIS SUPPLEMENTAL REPORT IS BEING COMPLETED TO INCLUDE THE DEVICE EVALUATION. DEVICE FORWARDED TO ENGINEERING. ONE DEVICE WAS RETURNED FOR EVALUATION. THE ANCHOR WAS VISUALLY INSPECTED AND WAS CONFIRMED TO BE BROKEN AT THE SUTURE EYELET LOCATION. CAPA (B)(4) HAS BEEN INITIATED TO ADDRESS THIS ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BROKE OFF DURING USE, PIECE STAYED IN BONE. SALES REP. INDICATED THAT PRIOR TO ROTATOR CUFF SURGERY, THE SURGEON DID NOT PREP THE SITE BUT INSTEAD JUST TAPPED IT ENOUGH TO GET THE ANCHOR STARTED. DURING INSERTION, THE ANCHOR BROKE AND REMAINED IN THE BONE. SURGEON PLACED ANOTHER ANCHOR IN ANOTHER LOCATION TO COMPLETE THE PROCEDURE. ROB STATED THAT THE DEVICE WAS RETURNED TO OKC IMMEDIATELY AFTER CALLING IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWINFIX ULTRA - TI TWINFIX ULTRA TI 4.5 W/2 UB MBI SMITH & NEPHEW MANSFIELD MANUFACTURING SITE 72202893 50410786

    Patients

    Seq Age Sex Outcome Treatment
    1