BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUNCH, STD 2.75MM, 15 DEG UP CURVED

    MDR report key: 2032210 · Received March 29, 2011

    Report

    Report Number
    1220246-2011-00059
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. IF THE DEVICE IS RETURNED FOR EVALUATION AND ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    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. COMPLAINT CONFIRMED. COMPLAINANT'S EVENT CAUSED BY A BROKEN TIP PIN AND ALSO HAS A BENT SHAFT. THIS TYPE OF EVENT IS TYPICALLY CAUSED BY APPLYING LEVERAGING FORCES. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED FROM THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PIN AT JAW CAME LOOSE DURING SURGERY AND IS NOW IN THE PATIENTS KNEE. DATE OF 2ND SURGERY NEEDS TO BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUNCH, STD 2.75MM, 15 DEG UP CURVED INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other