BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMPOSITE SWIVELOCK

    MDR report key: 5697847 · Received June 3, 2016

    Report

    Report Number
    1220246-2016-00244
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    April 5, 2012
    Report Date
    May 13, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K101823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS ONE OF FOUR SUBMISSIONS FROM THE SAME PATIENT CASE. THE OTHERS ARE 1220246-2016-00243-LINE 161726, 1220246-2016-00245-LINE 161728 AND 1220246-2016-00246-LINE 161729. 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 CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION 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. POST-OPERATIVELY, UNTIL HEALING IS COMPLETE, THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POST-OPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE IMPLANT. 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. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT SHOULDER ARTHROSCOPIC LIMITED DEBRIDEMENT, ARTHROSCOPIC SUBACROMIAL DECOMPRESSION INCLUDING ACROMIOPLASTY AND RIGHT SHOULDER OPEN LONG HEAD BICEPS TENODESIS PROCEDURES ON (B)(6) 2011. DURING THE (B)(6) 2011 PROCEDURES, PATIENT RECEIVED 4 IMPLANTS: AR-1680BC LOT 361229 (LINE (B)(4)), AR-2323BCC LOT 447144 (LINE (B)(4)), AR-2324BCCTT LOT 432598 (LINE (B)(4)) AND AR-2324BCCT LOT 432593 (LINE (B)(4)). PATIENT WAS NOTED TO HAVE SUBSEQUENTLY SUSTAINED A RECURRENT ROTATOR CUFF TEAR. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2012. OP REPORT FOR THE REVISION SURGERY NOTES A SUTURE ANCHOR WAS FRACTURED WITH MULTIPLE FRACTURES IN THE SUBACROMIAL SPACE AND ALSO NOTES A SECOND LOOSE SUTURE ANCHOR WAS IDENTIFIED ON PRE-OPERATIVE MRI WHICH COULD NOT BE LOCATED DURING PROCEDURE. REPORT ALSO NOTES A LOOSE SUTURE ANCHOR WAS LOCATED ADJACENT TO THE CORACOBRACHIALIS. OP REPORT DOES NOT SPECIFY WHICH ANCHORS FROM THE ORIGINAL (B)(6) 2011 PROCEDURE WERE EXPLANTED. OP REPORT ALSO NOTES THAT THE QUALITY OF THE BONE WAS NOTED TO BE SOFT. PATIENT HAD EXTENSIVE SUB-ACROMIAL BURSITIS AND SCARRING AS WELL AS A LARGE ROTATOR CUFF TEAR. SURGEON DECIDED TO CONVERT TO AN OPEN PROCEDURE. DURING THE REVISION, THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: AR2323BCC LOT 470065, AR-2323BCC LOT 470100, AR-7237-7 LOT 462939 AND AR-7237-7T, LOT 362291.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351062 BIO-COMPOSITE SWIVELOCK FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 447144

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other