BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WURAPA PIN DISTRACTOR

    MDR report key: 3162622 · Received April 25, 2013

    Report

    Report Number
    1833053-2013-00001
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    August 13, 2012
    Report Date
    April 23, 2013
    Manufacturer
    G.HIPP AND SOHN
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IMPORTER WAS ALERTED BY DISTRIBUTOR THAT A COMPLAINT WAS RECEIVED FROM A PHYSICIAN REGARDING A MALFUNCTION OF PART NUMBER 1752. DURING FOOT SURGERY, THE DISTAL TIP OF THE DEVICE BROKE AS THE PHYSICIAN ATTEMPTED TO INCREASE DISTRACTION. ACCORDING TO THE PHYSICIAN, THE SURGERY WAS ABLE TO BE COMPLETED USING A TOWEL CLIP AND THAT NO INJURIES WERE SUSTAINED BY THE PATIENT. A PICTURE OF THE BROKEN DEVICE WAS FORWARDED TO THE IMPORTER BY THE DISTRIBUTOR, AND THE IMPORTER IN TURN FORWARDED THE PICTURE TO THE MANUFACTURER. THE IMPORTER ALSO REQUESTED THAT THE DISTRIBUTOR FORWARD THE BROKEN DEVICE SO THAT IT COULD BE EVALUATED BY THE MANUFACTURER. THE IMPORTER ARRANGED A CONFERENCE CALL WITH THE MANUFACTURER TO DISCUSS THE COMPLAINT AND DETERMINE A ROOT CAUSE. BASED ON INPUTS FROM THE MANUFACTURER AND THE QUALITY ASSURANCE TEAM FROM THE IMPORTER, THE FOLLOWING SUMMARY WAS DEDUCED. THE WELDING FAILED AT THE JUNCTION WHERE THE DISTAL PIN AND THE DEVICE LEG MEET. THE ROOT CAUSES WERE DETERMINED TO BE THE FOLLOWING: THE WORKER DID NOT TACK ON BOTH SIDES OF THE ITEM; NO PRONOUNCED SEAM AROUND THE WELD; FINAL INSPECTION ACTIVITY DID NOT VERIFY THAT BOTH SEAMS WERE WELDED; WELDING ACTIVITY WAS NOT PERFORMED AT 360 DEGREES, AND 5; THE WORKER DID NOT ACCURATELY FOLLOW THE PROCEDURE.

    Description of Event or Problem · 1

    DISTRACTOR WAS HOLDING THE METATARSAL/PHALANX APPROPRIATELY. SURGEON WANTED A LITTLE MORE DISTRACTION AND THE TIP BROKE OFF ON THE FINAL CLICK. CASE WAS ABLE TO BE COMPLETED BY UTILIZING A TOWEL CLIP ON THE PROXIMAL PHALANX. PATIENT WAS A 52 YEAR OLD FEMALE. BONE QUALITY WAS FINE. NO INJURIES WERE SUSTAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181055 WURAPA PIN DISTRACTOR LXH G.HIPP AND SOHN 1752 55741230

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR