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

Catalog Number UNK GII ANCHOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer 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.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).

Event Description

This report is being filed after the review of the following journal article: tamai, k., "clinical results of bankart repair with suture anchors" (japan) this study emphasizes on analyzing the clinical results of the bankart repair using suture anchors as compared to those of the conventional transosseous suture technique.The patients evaluated on course of this study: 83 shoulders in 83 patients with recurrent anterior instability of the shoulder of traumatic origin who underwent bankart repair and followed up for more than one year after surgery.There were 68 males and 15 females.The age at operation ranged from 15 to 60 (average, 25) years.Of the 83 patients, 46 were operated with the conventional transosseous suture technique (group t|, 15 with statak soft-tissue attachment device (group s), and 22 with mitek g ii anchor (group m).The average follow-up period was 3.7, 2.2 and 1.5 years, respectively.The functional results were assessed with rowe's scoring system (1978).The recurrence was recorded in one patient (2.2%) in group t, 5 (33%) in group s and 3 (14%) in group m.The rowe's score totaled 55-100 (average, 89) in group t, 15-100 (average, 72) in group s and 25- 100 (average, 83) in group m.Excellent and good results were obtained in 40 (87%), 9 (60%) and 18 (82%) patients, respectively.Dislodgment of the suture anchor was encountered once in a patient in group m.When the fair and poor results were analyzed, limitation of postoperative shoulder motion was the major hindrance to satisfactory function in group t, whereas the high recurrence rate was in group s and group m.The article describes the following procedure: bankart repair with suture anchors the devices involved were: 46 were operated with the conventional transosseous suture technique (group t|, 15 with statak soft-tissue attachment device (group s), and 22 with mitek g ii anchor (group m) complications mentioned in the article were: - dislodgment of the suture anchor was encountered once in a patient in group m.

• 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: 9271891
• MDR Text Key: 184995907
• Report Number: 1221934-2019-59417
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/31/2019
• 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