BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINFIX ULTRA

    MDR report key: 3211204 · Received July 8, 2013

    Report

    Report Number
    1219602-2013-00155
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ONE DELIVERY DEVICE WAS RETURNED FOR EVALUATION. NO ANCHOR WAS RETURNED FOR EVALUATION. THE REPORTER WAS ABLE TO CONFIRM THE SITE PREPARATION WAS PERFORMED ACCORDING TO THE IFU BY USING A 5.5/6.5 AWL DILATOR, AS INDICATED IN THE IFU FOR GENERAL USE. WHILE SITE PREPARATION WAS PROVIDED, THE PATIENT¿S BONE QUALITY WAS NOT AVAILABLE. THE MANUFACTURER RECOMMENDS ¿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. 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 ANY OF THE REPORTED LOT NUMBERS ON FILE. AT THIS TIME IT IS UNCLEAR WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED ISSUE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE, TWO DOCTORS EXPERIENCED THE SAME PROBLEM. THEY BOTH USED THE SPECIFIC AWL TO PREPARE THE ANCHOR IMPLEMENTATION BUT WHEN THE ANCHOR WAS PLACED ON THE BONE IT BROKE. ONE SURGEON EXPERIENCED THE SAME PROBLEM THREE TIMES AND ANOTHER SURGEON ONE TIME. THE FACILITY IS RETURNING ONLY ONE ANCHOR, BUT WE KNOW THE CODES/BATCHES OF ALL THE BROKEN SCREWS. 72202602 BATCH 50417996 (2 PIECES, 1 RETURNED) AND 50429269 (2 PIECES). IT IS UNKNOWN WHICH OF THE ANCHORS BROKE DURING WHICH PROCEDURE. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS. THE ANCHOR BROKE AT THE DISTAL EYELET. THE SITE PREP WAS TAPPED. ALL BROKEN PIECES WERE REMOVED WITH GRASPERS AND NOTHING WAS LEFT IN THE PATIENT¿S BODY. SEVERAL REQUESTS WERE MADE FOR THE RETURN OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310799 TWINFIX ULTRA TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL MAI MANSFIELD MANUFACTURING SITE 72202602 50417996

    Patients

    Seq Age Sex Outcome Treatment
    1