BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITINOL GUIDE PIN. BIO- INTERFERENCE SCREW 1.1MM

    MDR report key: 3040447 · Received April 8, 2013

    Report

    Report Number
    1220246-2013-00049
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    July 1, 2012
    Report Date
    March 13, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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 REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THIS TYPE OF EVENT IS TYPICALLY CAUSED BY EXCESSIVE DRIVER FORCE APPLIED OVER THE GUIDE PIN, DRIVER TIP HITTING A FLEX POINT OF THE GUIDE PIN, PRYING/LEVERAGING ON THE GUIDE DURING USE AND/OR RE-USING A GUIDE PIN FROM THE SINGLE-USE DISPOSABLE KIT THAT HAS BEEN BENT FROM PRIOR USE. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE RETURN EXPECTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ACL WAS PERFORMED ON (B)(6) 2012 AND THE CASE WENT WELL. THE REP WAS NOTIFIED THAT EVEN THOUGH THE PATIENT HAD NO PAIN, UPON ROUTINE X-RAYS, THE SURGEON NOTICED THAT A PIECE OF THE SCREW GUIDEWIRE WAS SNAPPED OFF IN THE JOINT (ABOUT 2CM). THE SURGEON RETRIEVED THE GUIDE WIRE FROM THE JOINT WITHOUT DAMAGING THE GRAFT. THE PATIENT IS DOING FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142770 NITINOL GUIDE PIN. BIO- INTERFERENCE SCREW 1.1MM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other