BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - IMPLANTS - VERSALOK

    MDR report key: 9233122 · Received October 24, 2019

    Report

    Report Number
    1221934-2019-59187
    Event Type
    Injury
    Date Received
    October 24, 2019
    Report Date
    October 22, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN IMPLANT DEVICE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 OF THE SHOULDER FOR THE SAME EVENT. THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MCLAUGHLIN-SYMON, I., ET AL. (2015) "A NEW "TRAPDOOR TECHNIQUE" FOR FIXATION OF DISPLACED GREATER TUBEROSITY FRACTURES OF THE SHOULDER", VOL. 7, NO. 2, PAGES 241-243 (INDIA). THIS STUDY EMPHASIZES ON A NEWLY DESCRIBED VERSATILE TECHNIQUE THAT CAN BE USED REGARDLESS OF THE SIZE AND COMMINUTION OF THE TUBEROSITY FRAGMENT AND CAN BE PERFORMED EITHER OPEN OR ARTHROSCOPICALLY. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: ALL THEIR PATIENTS HAD SUSTAINED ISOLATED GREATER TUBEROSITY FRACTURES AND WERE OPERATED UNDER GENERAL ANAESTHESIA WITH ANTIBIOTIC COVER, ACCORDING TO LOCAL POLICY, IN A BEACH CHAIR POSITION. THEY PRESENT A NEW SURGICAL "TRAPDOOR" TECHNIQUE FOR FIXATION OF ISOLATED GREATER TUBEROSITY FRACTURES WHICH CAN AVOID THESE PROBLEMS AND BE UTILIZED EITHER OPEN OR ARTHROSCOPICALLY. FOLLOWING REDUCTION OF THE ISOLATED GREATER TUBEROSITY FRAGMENT, TWO DOUBLE LOADED METAL SCREW IN ANCHORS ARE PLACED THROUGH STAB INCISIONS IN THE ROTATOR CUFF AT THE BONE-TENDON INTERFACE AND SECURED INTO THE HUMERAL HEAD. A SUTURE FROM EACH OF THE ANCHORS IS TIED TOGETHER TO SECURE THE TUBEROSITY FRAGMENT PROXIMALLY AND A SUTURE-LESS ANCHOR IS INSERTED DISTAL TO THE FRACTURE SITE FORMING AN INVERTED TRIANGLE. THE REMAINING SUTURES ARE PLACED THROUGH THE SUTURE-LESS ANCHOR AND TENSIONED INDEPENDENTLY. AS THE SUTURES ARE TIED AND SNUGGED TIGHT, THE DISTAL ASPECT OF THE FRACTURE REDUCES, THUS CLOSING THE "TRAPDOOR". CHECK RADIOGRAPHS ARE TAKEN AT 2 AND 6 WEEKS POSTOPERATIVELY TO ENSURE THAT NO DISPLACEMENT HAS OCCURRED (FIG. 5 RADIOGRAPH OF POST-OPERATIVE TUBEROSITY FIXATION). SUBSEQUENT FOLLOW UP OCCURS AT 3 AND 6 MONTHS POSTOPERATIVELY FOR A CLINICAL ASSESSMENT. BY 6 WEEKS 57 % OF PATIENTS HAVE ACHIEVED FLEXION AND ABDUCTION OF AT LEAST 90°. 28 % OF OUR PATIENTS HAVE ACHIEVED A FULL RANGE OF MOVEMENT WHEN COMPARED TO THE CONTRALATERAL SHOULDER AT 3 MONTHS AND BY 6 MONTHS THIS HAS INCREASED TO 85 % OF PATIENTS. TO DATE WE HAVE HAD ONE COMPLICATION IN WHICH AN ANCHOR WAS ADVANCED TOO FAR INTO THE HUMERAL HEAD AND APPEARED TO HAVE PENETRATED THE ARTICULAR SURFACE ON FOLLOW UP RADIOGRAPHS. A SUBSEQUENT REPEAT ARTHROSCOPY REVEALED THAT THE ANCHOR HAD PENETRATED POSTERIORLY IN A NON-ARTICULATING PART OF THE HUMERAL HEAD. THERE WERE NO ASSOCIATED CLINICAL SYMPTOMS AND THE PATIENT WAS FOLLOWED UP FOR A YEAR WITH REPEAT RADIOGRAPHS, WHICH SHOWED UNION OF THE GREATER TUBEROSITY FRACTURE AND NO EVIDENCE OF ANCHOR MIGRATION. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: "TRAPDOOR TECHNIQUE" FOR FIXATION OF DISPLACED GREATER TUBEROSITY FRACTURES. THE DEVICES INVOLVED WERE: TWO METAL SCREW IN SUTURE ANCHORS OF AT LEAST 5 MM DIAMETER AND DOUBLE LOADED WITH ORTHOCORD ARE PLACED THROUGH STAB INCISIONS IN THE ROTATOR CUFF AT THE BONE-TENDON INTERFACE AND SECURED INTO THE HUMERAL HEAD. THE REMAINING SUTURES FI-OM EACH OF THE DOUBLE-LOADED ANCHORS ARE INSERTED THROUGH THE VERSALOK. THE SUTURES CAN NOW BE TENSIONED INDEPENDENTLY USING THE VERSALOK. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: TO DATE WE HAVE HAD ONE COMPLICATION IN WHICH AN ANCHOR WAS ADVANCED TOO FAR INTO THE HUMERAL HEAD AND APPEARED TO HAVE PENETRATED THE ARTICULAR SURFACE ON FOLLOW UP RADIOGRAPHS. A SUBSEQUENT REPEAT ARTHROSCOPY REVEALED THAT THE ANCHOR HAD PENETRATED POSTERIORLY IN A NON-ARTICULATING PART OF THE HUMERAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026873 UNK - IMPLANTS - VERSALOK SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention