BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-INTERFERENCE SCREW

    MDR report key: 3080550 · Received April 26, 2013

    Report

    Report Number
    1220246-2013-00061
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. COMPLAINANT'S EVENT TYPICALLY CAUSED BY NOT INSERTING THE IMPLANT CO-AXIAL TO THE BONE TUNNEL, PRYING/LEVERAGING THE IMPLANT, FLEXING THE JOINT DURING INSERTION OR IMPROPER BONE PREPARATION. 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 WHEN THE SCREW WAS INSERTED WITH THE GUIDEWIRE, IT BROKE ABOVE ITS TIP (1/4 AT ENTRY AFTER CONTACT WITH THE BONE OF THE TIBIA). CUSTOMER SAID THAT THE BROKEN PIECE WAS LEFT INSIDE THE PATIENT AND THEY TRIED ANOTHER SCREW ((B)(4)). THEY HAD TO USE THE SPIKED LIGAMENT STAPLE ((B)(4)) BECAUSE THE NEW SCREW WOULD NOT HOLD DUE TO THE BROKEN PIECE INSIDE. SURGERY WAS SUCCESSFULLY COMPLETED AND PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182258 BIO-INTERFERENCE SCREW FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 437991

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) BIO-INTERFERENCE SCREW LOT 38740