BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE INTERFERENC SCREW W/ DISP SHEATH

    MDR report key: 2982786 · Received February 28, 2013

    Report

    Report Number
    1220246-2013-00021
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. RETURNED DEVICE INCLUDES ONE DEVICE IN ITS SEALED ORIGINAL PACKAGE AND ANOTHER BROKEN SCREW. SCREW IS BROKEN AT APPROXIMATELY THE 4TH. THREAD FROM THE HEAD OF THE SCREW. THE MOST LIKELY CAUSE OF THE EVENT IS AS REVEALED IN A POST-EVALUATION FOLLOW-UP WHICH SHOWED THE SURGEON WAS USING A DRIVER WITH A BENT TIP WHEN HE DID THIS SURGERY. SINCE THEN, THE DRIVER HAS BEEN REPLACED AND DISCARDED. 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 THE SCREW BROKE DURING INSERTION. THE BROKEN PIECE WAS NOT REMOVED FROM THE PATIENT AND NOTHING WAS INSERTED ON TOP OF IT. SURGEON STATED THAT ABOUT 13MM OF THE IMPLANT REMAINED. PROCEDURE WAS AN ACL.THE SURGEON TAPPED PRIOR. ANOTHER IMPLANT WAS NOT INSERTED AS HE FELT THE FIXATION WAS STABLE AND WAS SATISFIED WITH THE REPAIR. PATIENT IS FINE TO DATE. THIS IS ONE OF THREE SIMILAR EVENTS INVOLVING THE SAME DEVICE FROM THE SAME FACILITY AND BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87480 BIOCOMPOSITE INTERFERENC SCREW W/ DISP SHEATH FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 583955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other