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 Joint Dislocation (2374); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown gii anchor.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.(b)(4).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.

Event Description

This report is being filed after the review of the following journal article: tanabe tomohiro et al, 1996, ¿result of a bankart operation for recurrent anterior instability of the shoulder¿, the shoulder joint vol.20 no.2 313-316, japan.The study emphasizes on evaluation of the bankart repair for traumatic recurrent anterior shoulder dislocation using mitek gii anchor.The patients evaluated on course of this study: three kinds of open bankart operation were performed for 71 shoulders of 71 patients with traumatic recurrent anterior shoulder dislocation and subluxation, and the postoperative results were investigated.The subjects were 71 shoulders of 71 patients who had been directly examined, consisting of 57 males and 14 females among 84 cases for whom 6 months or more had passed following open bankart operation at an orthopedic hospital or associated facilities.Age at first dislocation was 12 to 45 years (mean 19 years old), age at the time of operation was 15 to 60 years (mean 25 years old), the dislocation frequency was 3 to 102 times (mean 14 times), and the follow-up period was 0.5 to 6.9 years (mean 2.8 years).The article describes the following procedure: performed bankart repair for traumatic recurrent anterior shoulder dislocation and subluxation since 1988.At first, adopted a surgical procedure in which a bone hole was provided on the margin of the glenoid fossa and the articular capsule was sewed according to modification modified method by rowe3) (hereinafter, rowe method), but since 1991, we have attempted a surgical procedure using an anchor device, keeping in mind use in future endoscopic operations.Here, the report on an investigation of whether or not there are differences in results depending upon the surgical procedure.The devices involved were: unknown mitek gii anchor was used to bankart repair for traumatic recurrent anterior shoulder dislocation.Complications mentioned in the article were: following complications were reported in bankart repair for traumatic recurrent anterior shoulder dislocation and subluxation in which mitek gii anchor device was used: out of postoperative results for all cases, re-dislocation or re-subluxation was seen in 5 cases (7%).According to rowe evaluation, 61 cases or 86% scored excellent or good, ranging from 15 to 100 points with an average of 87 points.In terms of surgical procedure, the highest postoperative rowe evaluation was 89 points, with no cases of re-dislocation with rowe method.The statak group statistically was significantly high in re-dislocations and re-subluxations (p < 0.01), and according to rowe evaluation the percentages of excellent and good were both low in 8 out of 12 cases with a mean of 77 points.There was a case of re dislocation in mitek group, but according to rowe evaluation the percentages of excellent and good were the most highest among the 3 groups.

• 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 ; 5088808100
• MDR Report Key: 8767977
• MDR Text Key: 150284365
• Report Number: 1221934-2019-57549
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• 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
• Date Manufacturer Received: 06/13/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention