BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMPOSITE CORKSCREW FT VENTD 5.5X14.7MM

    MDR report key: 6996484 · Received November 2, 2017

    Report

    Report Number
    1220246-2017-00415
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    June 16, 2015
    Report Date
    November 2, 2017
    Manufacturer
    ARTHREX INC.
    Product Code
    MAI
    UDI-DI
    00888867023390
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    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. THIS IS ONE OF TWO SUBMISSIONS FROM THE SAME CASE. THE OTHER IS (B)(4). DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. 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. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING 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 PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE WITH 5-6 ANCHORS INTO HER SHOULDER. THE PATIENT STATES THAT THE SHE BEGAN TO EXPERIENCE HEAT IN HER SHOULDER AND THE ANCHORS HAVE EATEN AWAY AT HER TISSUE/MUSCLE. THE ANCHORS HAVE SINCE BEEN REMOVED IN A REVISION SURGERY. NO CASE INFORMATION AND NO FURTHER DETAILS WERE PROVIDED AT THE TIME OF INITIAL REPORT. THE FOLLOWING INFORMATION WAS OBTAINED FROM PATIENT MEDICAL RECORDS: ORIGINAL ROTATOR CUFF SURGERY WAS (B)(6) 2014. REVISION SURGERY WAS (B)(6) 2015. ROTATOR CUFF REPAIR IMPLANT LOG-DATED (B)(6) 2014: PARTS USED DURING PROCEDURE: AR-1927BCFT, LOT 1190433, QTY 3 ((B)(4)) AR-1922BC, LOT 1183470, QTY 2 ((B)(4)) OPERATIVE REPORT DATED (B)(6) 2014: HEMOSTASIS WAS OBTAINED WITH ELECTRO-CAUTERY. THE OPERATIVE ASSISTANT FACILITATED THE ALTERNATING USE OF THE SHAVER AND THE ELECTROCAUTERY. PHYSICIAN OFFICE RECORDS DATED (B)(6) 2015: PATIENT REPORTED STILL HAVING SOME TROUBLE WITH LIFTING HER ARM ABOVE HER SHOULDER. PHYSICIAN OFFICE RECORDS DATED (B)(6) 2015 PATIENT REPORTED HAVING ISSUES WITH WEAKNESS, STILL SOME SORENESS BUT NOT AS BAD. AND DIFFICULTY LIFTING HER ARM. PHYSICIAN OFFICE RECORDS DATED (B)(6) 2015: SURGEON IS CONCERNED WITH A RECURRENT CUFF TEAR. MRI ORDERED. PHYSICIAN OFFICE RECORDS DATED (B)(6) 2015: PATIENT REPORT NOT HAVING A LOT OF PAIN. STRENGTH CONTINUES TO BE LESS THAN SATISFACTORY FOR HER. HAS CONTINUE WITH THERAPY. NOW ABLE TO HOLD HER ARM OUT BUT UNABLE TO ELEVATE HER ARM TO ANY GREAT DEGREE. NO NUMBNESS OR TINGLING. PATIENT RETURNED TO WORKING OUT AT GYM AND HAS BEEN HAVING SOME POSTERIOR SCAPULAR PAIN. SECOND OPINION SET UP FOR PATIENT. MRI RESULTS DATED (B)(6) 2015: INTERVAL RCR INVOLVING THE SUPRASPINATUS TENDON AND ANTERIOR INFRASPINATUS TENDON. MARKED ATTENUATION OF RESIDUAL INTACT FIBERS OF BOTH REPAIRED TENDONS AND IS UNCERTAIN IF THIS REPRESENTS RECURRENT BROAD-BASED PARTIAL-THICKNESS TEARING VERSUS AN APPEARANCE RELATED TO THE ORIGINAL REPAIR. SMALLER FOCAL AREAS OF FULL-THICKNESS PERFORATION COULD NOT BE EXCLUDED ALTHOUGH THERE IS A LACK OF SIGNIFICANT CONTRAST THROUGHOUT THE SUBACROMIAL/SUBDELTOID BURSA WHICH WOULD ARC REVIEWED AGAINST FULL-THICKNESS DISRUPTION. NO TENDINOPATHY OF THE SUBSCAPULARIS TENDON. POSTOPERATIVE CHANGES OF INTERVAL SUBACROMIAL DECOMPRESSION WITH RESIDUAL MILD/MODERATE NARROWING OF THE ACROMIOHUMERAL SPACE. NO SIGNIFICANT GLENOHUMERAL JOINT ARTHROSIS, DISCRETE LABRAL TEARING OR BICEPS TENDON RUPTURE. OP REPORT DATED (B)(6) 2015: CUFF WAS SEVERELY THIN AND DEGENERATIVE. IT APPEARED TO BE NECROSED FROM POSSIBLE THERMAL ELECTROCAUTERY. THE ANCHORS DID NOT APPEAR TO BE AN ISSUE AS THERE WAS NOT LYSIS AROUND THE BONE. HOWEVER ANCHORS WERE REMOVED TO ALLOW FOR PROPER TRANSOSSEOUS TUNNEL. REVISION WAS COMPLETED USING SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775437 BIO-COMPOSITE CORKSCREW FT VENTD 5.5X14.7MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX INC. 1190433 00888867023390

    Patients

    Seq Age Sex Outcome Treatment
    1 Other