BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINITAC

    MDR report key: 2210831 · Received August 12, 2011

    Report

    Report Number
    1219602-2011-00132
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    SMITH & NEPHEW ASDD MANSFIELD MANUFACTURING SITE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION CONFIRMED THAT THE DEVICE WAS BEING USED OFF LABEL ON A BROWLIFT. (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE SHOWS THE DISTAL THREADS OF THE ANCHOR HAVE BROKEN OFF. NEEDLES HAVE BEEN REMOVED FROM THE HANDLE AND SUTURE. NO DAMAGE OBSERVED TO THE HEX PORTION OF THE INSERTER SHAFT OR THE ANCHOR. UNDER MICROSCOPIC EVALUATION IT WAS CONFIRMED THAT THERE ARE NO VISIBLE VOIDS OR CRACKS AT OR AROUND THE FAILURE POINT WHICH WOULD HAVE CONTRIBUTED TO THE FAILURE. THE SHAPE OF THE ANCHOR AT THE BREAKAGE POINT IS CONSISTENT WITH MATERIAL THAT HAS FAILED DUE TO TORSIONAL SHEAR. IT WAS NOTED THAT WHEN USED WITH THE PROPER DRILL IN CORRECT AXIAL ALIGNMENT, A FAILURE OF THIS TYPE IS HIGHLY IMPROBABLE DUE TO THE LIMITED INTERFERENCE BETWEEN THE ANCHOR AND THE RESULTING HOLE. IT IS NOT KNOWN WHICH TYPE OF PROCEDURE WAS BEING PERFORMED AND IF THE PRESCRIBED AO TWO-FINGER TECHNIQUE WAS USED DURING INSERTION. BASED ON THE PHYSICAL EVIDENCE, THE INFORMATION PROVIDED, AND THE ISOLATED NATURE OF THE INCIDENT, A ROOT CAUSE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SURGEON COULDN'T DRIVE ANCHOR INTO BONE, TRIED APPROPRIATE DRILL, STILL WOULDN'T WORK, ANCHOR SHEERED OFF INSERTER, PART LEFT IN PATIENT. SURGEON HAD TO RESORT TO OLD METHOD OF FIXATION. DELAY TO CASE 20MIN. PATIENT FEMALE, (B)(6) OLD, GOOD HEALTH. ADDITIONAL INFORMATION STATED IT WAS A SOFT TISSUE TO BONE REPAIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINITAC MNITAC,2.0 TI W/NDL,2#2-0 ULTRABRAID MBI SMITH & NEPHEW ASDD MANSFIELD MANUFACTURING SITE 72202019 50375412

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR