BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-COMP-SITE P-LCK 2.9X15.5MM

    MDR report key: 20260782 · Received September 19, 2024

    Report

    Report Number
    1220246-2024-07761
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 9, 2024
    Report Date
    January 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867023017
    PMA / PMN Number
    K173240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1923BC SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DEVICE WAS BROKEN WHEN RECEIVED. VISUAL INSPECTION REVEALED THAT THE INNER SHAFT TIP WAS BENT. THE REPORTED FAILURE ANCHOR WAS NOT RECEIVED FOR EVALUATION. THE METHOD OF BONE PREPARATION EMPLOYED DURING THE PROCEDURE, AS WELL AS THE BONE QUALITY ENCOUNTERED, WAS NOT PROVIDED. THE OUTER SHAFT OUTSIDE DIAMETER WAS MEASURED BY DRAWING C6878 AT REVISION 6 Ø 062 ± .001, RESULTING IN 0.062. THE SHAFT IS IN TOLERANCE BY THE DRAWING SPECIFICATIONS. THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE CAN BE A USER ERROR DUE TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND/OR PRYING/LEVERING THE DEVICE DURING INSERTION. ACCORDING TO DIRECTION FOR USE. DFU-0087-EOR3_FMT_EN. G. PRECAUTIONS. 3. MAKE SURE TO USE THE RECOMMENDED DRILL BIT OR PUNCH TO CREATE THE BONE SOCKET. 4. PUSHLOCK AND SWIVELOCK SUTURE ANCHORS ONLY: DURING ANCHOR INSERTION, ENSURE THAT THE ANGLE OF ANCHOR INSERTION IS COAXIAL TO THAT OF THE PREVIOUSLY PREPARED BONE SOCKET. 5. PUSHLOCK AND SWIVELOCK SUTURE ANCHORS ONLY: INSERT THE DRIVER INTO THE BONE SOCKET UNTIL THE ANCHOR BODY MAKES CONTACT WITH THE BONE. PREVIEW AND ADJUST SUTURE TENSION, IF NECESSARY. TENSION WILL NOT INCREASE DURING FINAL ADVANCEMENT OF THE ANCHOR BODY. 8. SELF-PUNCHING PUSHLOCK AND SWIVELOCK SUTURE ANCHORS ONLY: ENSURE THAT THE ANGLE OF ANCHOR INSERTION IS PERPENDICULAR TO THE BONE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE ANCHOR BROKE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. 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
    2335721 BIO-COMP-SITE P-LCK 2.9X15.5MM BIO SOFT TISSUE FIXATN FASTNR MAI ARTHREX, INC. BIO-COMP-SITE P-LCK 2.9X15.5MM 15197029 00888867023017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown