BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSION FT SCREW, 2.5 MICRO, 28MM LENGTH

    MDR report key: 4192873 · Received October 22, 2014

    Report

    Report Number
    1220246-2014-00202
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K132217
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS RECEIVED AND AN EVALUATION WAS CONDUCTED. THE COMPLAINT WAS CONFIRMED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE EVALUATION REVEALED THAT THE RETURNED SCREW'S PROXIMAL HEXAGONAL DRIVE IS STRIPPED. THE COMPLAINANT'S EVENT WAS MOST LIKELY CAUSED BY IMPROPER SURGICAL TECHNIQUE BECAUSE AS REPORTED, SURGEON WAS INFORMED THAT THE CURRENT TECHNIQUE WAS TO USE THE 2.2 DRILL BIT ALONG WITH THE PROFILE DRILL FOR THE 2.5 SCREWS TO LOWER THE INSERTION TORQUE. HE DID NOT THINK IT WAS NECESSARY AND JUST USED THE 1.7 DRILL ALL THE WAY DOWN THE K-WIRE AND THEN INSERTED THE 2.5 COMPRESSION SCREW. THE SURGICAL TECHNIQUE RECOMMENDS USING A 2.2 MM DRILL FOR THE 2.5 MICRO-COMPRESSION FT SCREWS WHEN PRE-DRILLING THE BONE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIP FUSION (DISTAL INTERPHALANGEAL) OF THE FINGER JOINT CASE, THE SURGEON WAS INFORMED THAT THE CURRENT TECHNIQUE WAS TO USE THE 2.2 DRILL BIT ALONG WITH THE PROFILE DRILL FOR THE 2.5 SCREWS TO LOWER THE INSERTION TORQUE. HE DID NOT THINK IT WAS NECESSARY AND JUST USED THE 1.7 DRILL ALL THE WAY DOWN THE K-WIRE AND THEN INSERTED THE 2.5 COMPRESSION SCREW. WHEN IT WAS 3/4 OF THE WAY IN IT STRIPPED. HE WAS ABLE TO REMOVE IT AND THEN DECIDED TO DRILL WITH THE 2.2 BIT AND THE PROFILE DRILL. AT THIS POINT HE INSERTED A NEW SCREW OF THE SAME DIMENSIONS. HE WAS ABLE TO INSERT IT ALL THE WAY BUT WAS NOT GETTING ADEQUATE COMPRESSION. HE CONTINUED TO DRIVE THE SCREW IN AND EVENTUALLY IT STRIPPED. AT THIS POINT HE COULD NOT REMOVE IT. HE PINNED THE FINGER ABOVE AND BELOW THE SCREW WITH K-WIRES IN ATTEMPT TO GET SOME COMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670838 COMPRESSION FT SCREW, 2.5 MICRO, 28MM LENGTH SCREW, FIXATION, BONE HWC ARTHREX, INC. 1163807

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other