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

Catalog Number UNK GII ANCHOR

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Tissue Damage (2104); Not Applicable (3189)

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 is report 2 of 2 for the same event.This report is being filed after the review of the following journal article: roderich heikenfel et al, ¿arthroscopic single or double row repair of isolated full thickness ssp tear - prospective results after 24 months¿.The journal of arthroscopic and related surgery vol 28 number 6 pages e10, usa.The purpose of the study was to evaluate the results after arthroscopic reconstruction of isolated ssp lesions.Does double row repair in smaller lesions lead to better results and a lower retear rate? the patients evaluated on course of this study: 80 patients with an isolated full thickness ssp tear was divided into 2 groups.Group i (27 men, 13 women, average age 57 yrs.) was repaired using a single row technique with 2 anchors (mitek fasrin) with arthroscopic mason-allen stitches.Group 2 was repaired using a double row technique using i medial anchor (mitek fasrin) and 2 lateral anchors (versalok).The article describes the following procedure: pre-op an ultrasound and mri were obtained as well as standard x-rays.Included to this study were only patients matching the following criteria: intraoperative cartilage lesions < = outer bridge grade2, fatty degeneration <= goutallier grade 2, ap extent of the tear < 2,5 cm.Prospective follow up after 6, 12- and 24-months using ucla and constant score as well as mri at last follow up.The devices involved were: 2 anchors (mitek fasrin) and 2 lateral anchors (versalok) complications mentioned in the case report were: 37 patients in group 1 and 36 patients in group 2 were completely evaluated.Both groups showed improvement in constant score from 49,3 to 89,4 in group 1 (single row) compared to 47,6 and 90,7 in group 2 (double row).Mri at last follow up showed 4 retears in the single row group and 3 retears in the double row group.1 shoulder in the double row group needed revision due to a loose anchor.

• 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: 9261733
• MDR Text Key: 183567872
• Report Number: 1221934-2019-59353
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 10/29/2019
• 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