BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL SYS,BIO-COMP ACHILLES SPEEDBRG

    MDR report key: 17711887 · Received September 8, 2023

    Report

    Report Number
    1220246-2023-07830
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    July 13, 2023
    Report Date
    January 14, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867049123
    PMA / PMN Number
    K101823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE CUSTOMER-PROVIDED PHOTO WHICH DISPLAYS A SWIVELOCK WITH A DAMAGED TIP. REFER TO ATTACHMENTS. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING USED DURING INSERTION AND/OR IMPROPER BONE PREP. THE BONE QUALITY OF THE PATIENT AND THE INFORMATION OF THE INSTRUMENT USED TO PREPARE THE BONE SOCKET FOR INSERTION OF THE IMPLANT WERE NOT PROVIDED. PER DFU-0087-EO REVISION 3, E. WARNINGS 6. BIOABSORBABLE ONLY: ATTEMPTING IMPLANTATION INTO HARD, DENSE BONE AND/OR DRILLING/PUNCHING SMALLER DIAMETER HOLES THAN RECOMMENDED MAY CAUSE FAILURE (BREAKAGE) OF THE IMPLANT DURING INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ACHILLES SPEEDBRIDGE AND FHL TRANSFER SURGERY UPON INSERTION OF A SINGLE SWIVEL LOCK FROM THE SPEED BRIDGE KIT, THE INSERTER WRAPPED ITSELF AROUND THE SCREW AND THE MECHANISM SEIZED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-2324BCC). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664006 IMPL SYS,BIO-COMP ACHILLES SPEEDBRG BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. IMPL SYS,BIO-COMP ACHILLES SPEEDBRG 15087254 00888867049123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown