MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GII ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number UNK GII ANCHOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 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.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).

Event Description

This is report 2 of 2 for the same event.This report is being filed after the review of the following journal article: hans rahme, et al, 2010 ¿loss of external rotation after open bankart repair: an important prognostic factor for patient satisfaction¿, knee surgery sports traumatol arthrosc 18: pages 404-408 (sweden) the aim of this study was therefore to ascertain the impact of loss of external rotation on patient satisfaction 5 years (on average) after surgery among patients who had undergone open bankart repair according to rowe's modified technique.68 consecutive patients operated for recurrent traumatic unidirectional anterior instability of the glenohumeral joint to assess the association between loss of external rotation and patient satisfaction.All patients underwent open bankart repair.Two independent observers carried out a follow-up (5 years on average) after surgery.The article describes the following procedure: the modified bankart operation was done under general anaesthesia with the patient in a supine position and the upper body elevated approximately 20°.A standard deltopectoral approach was used.At the beginning of the series, the coracoid process was osteotomized in 12 shoulders before the introduction of suture anchors.The subscapularis was divided into an l-shaped fashion and separated from the underlying capsule.If the rotator interval was widened, it was partially closed before opening of the capsule.Depending on the degree of capsular laxity, the capsule was then divided vertically 5-10 millimetres from the glenoid rim.The device involved: two to four mitek gi or gii suture anchors (mitek surgical products,(b)(4)).The average rowe score was 88 at the latest follow-up (average 66 months) compared to 63 before surgery.The 95% ci for the difference in pre-operative and the latest follow-up rowe score was 21-28 (p < 0.0001).At follow-up, recurrent dislocation had developed in four of the 68 patients (6%).The median pre-operative rowe score was 65 (range 42-87), which can be compared with 92 (range 46-100) at the follow-up.Three patients rated their outcome as poor, 13 as fair, 23 as good and 29 as excellent.Complications mentioned in the study: during follow-up, four patients had experienced at least one recurrence.Of these four patients, one had a single redislocation during sleep after 5 years, while the other three had several recurrences during sport activities.The three poor results were combined with glenohumeral osteoarthritis in one patient, several recurrences in another patient and a post-operative deep infection in one patient.One patient underwent arthroscopy and manipulation under anaesthesia 4 months post-operatively because of stiffness.Patients (n = 16) with loss of external rotation reported.From the review of the article it can be concluded that open bankart repair with a modified rowe procedure is an excellent surgical option regarding stability, but restriction in external rotation reduces the likelihood of a satisfied patient.A copy of this literature article is attached to this medwatch report.

• Brand Name: UNKNOWN GII ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9232885
• MDR Text Key: 172623455
• Report Number: 1221934-2019-59178
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK GII ANCHOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention