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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.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)].
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This report is being filed after the review of the following journal article: pierre moulinoux et al, 2007, "arthroscopic repair of rotator cuff tears ", operative orthopedics and traumatology volume 19 number 3 pages 213-254, france.The purpose of the study was to regain of shoulder function and freedom of pain through arthroscopic fixation of the torn rotator cuff using anchors and tension bands.The patients evaluated on course of this study: in the years 2001 and 2002, 50 patients were treated for avulsion or intrasubstance tearing of the supraspinatus by the senior surgeon.The tear was repaired with a single row of anchors and u-stitches.A tenodesis of the long head of biceps was performed in one patient, and a tenotomy in five.Before surgery the patients were assessed by their history, age, physical examination and complimentary examinations.The article describes the following procedure: surgeon performed subacromial bursoscopy.The posterolateral portal is placed 2 cm distal to the posterolateral angle of the acromion.The entry point to the anterolateral portal is found 2 cm distal to the anterolateral angle of the acromion.The lateral portal is placed 1 or 2 cm lateral to the acromion and 2 cm behind its anterior border.The entry point to the laterosuperior portal is placed 1-2 cm above the lateral portal under the lateral border of the acromion.Technique of one row of anchors was also performed.Freshening of the free end of the stump (cuff) with a basket forceps introduced through the lateral portal.A motorized shaver introduced through the same portal allows debridement of soft tissue from the rotator cuff footprint and from the superior surface of the greater tubercle.We use either an impacted anchor (mitek c2) or a screwed anchor.For anchor insertion along the superior part of the lateral surface of the greater tubercle, an inclination of 45° is used through the lateral subacromial portal.Insertion of a working cannula is not necessary, but for the insertion of the g2 anchor a 2.7-mm drill bit hole is required.Drilling is carried out through the lateral or laterosubacromlal portal.Each drill hole is immediately marked with the electrocautery knife to avoid confusion while drilling the second hole.External rotation brings the anterior aspect of the greater tubercle into view.In placement of the suture, surgeon used ethibond that is tied to the dps or placed in the loop of the shuttle relay.The anterior suture is withdrawn with the suture forceps through the lateral portal in order to get the two sutures through the lateral portal.This technique permits to make u-stitches that have a better purchase in the stump than simple stitches.Moreover, it allows a perfect and uniform approximation of the tendon stump to the freshened bony surface thanks to the tension band effect.Surgeon also performed glenohumeral arthroscopy and repair of supraspinatus using a posterior portal and an inside-out anterior portal, associated with one or two additional anterolateral portals.Attachment with a single row of anchors and tenotomy/tenodesis of long head of biceps is used if indicated.The devices involved were: 5.5 mm or the mitek g2 anchors (johnson and johnson, picataway, nj, usa) complications mentioned in the case report were: osteoarthritis of the acromioclavicular joint was noted in ten patients.Early glenohumeral osteoarthritis with moderate inferior marginal osteophytes were present in eight patients.An acromion type 2 was seen m 28 shoulders, and type 3 in 22 shoulders.An osteophytic spur was visualized in 19 patients.There was one diagnosis of os acromiale.A complete tear of the entire supraspinatus was diagnosed in 19 patients.An intratendinous delamination was seen in twelve patients.The ct scans also allowed the stage of fatty infiltration of the various rotator cuff muscles to be determined.Most were in stage i (37 stage i of supraspinatus, 35 stage i of infraspinatus, and 41 stage i of subscapularis).A posterior extension of the tear into the infraspinatus was seen three times and affected the anterior third.An intratendinous delamination was observed eight times.The superior part of the subscapularis tendon appeared abnormal in two patients.A tear of the long head of the biceps was diagnosed twice, and the tendon was uncovered in 14 patients.14 patients experienced slight pain: three had bicipital tendinopathy, four a persisting subacromial impingement, one an acromioclavicular arthropathy, two an atypical pain and an incomplete healing, and four a pain of unknown origin.The average duration of rehabilitation was 6.2 months, corresponding to the time to resumption of work and sport activities.We experienced eight postoperative complications: one avulsion of the anchor, six reruptures of the supraspinatus tendon, and one reflex sympathetic dystrophy.
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