MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANT

Device Problem Break (1069)

Patient Problem Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.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.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This file is a review of the following journal article: peters, k., et al (2018) a comparison of permanent anchors versus biodegradable anchors and tacks for arthroscopic shoulder stabilization.Techniques in shoulder & elbow surgery, vol.19, pages 1-7, (australia).The study emphasizes on the clinical outcomes of arthroscopic stabilization of patients with anterior glenohumeral instability using knotless devices made from 4 different materials.The patients evaluated on course of this study: 155 patients.The article describes the following procedure: arthroscopic shoulder stabilization.The device involved was: unknown bioknotless anchor.Complications described: the overall redislocation rate was 19% in the bioknotless group.Revision surgery for redislocation was performed in 10% in the bioknotless group.Intraoperatively, 1 inserter tip broke off in the bioknotless group.

• Brand Name: UNK - IMPLANT
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11568916
• MDR Text Key: 242680634
• Report Number: 1221934-2021-00973
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention