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

Catalog Number UNK - IMPLANT

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

Patient Problems Tissue Damage (2104); No Code Available (3191)

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 and 510-k number are unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Concomitant medical product: unknown implant.(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.

Event Description

This file is a review of the following journal article: xu, y., et al (2019) comparison of clinical and patient-reported outcomes of three procedures for recurrent anterior shoulder instability: arthroscopic bankart repair, capsular shift, and open latarjet.Journal of orthopaedic surgery and research, vol.14, pages 1-7, (china).The study emphasizes on the best surgical of recurrent anterior shoulder instability remained controversial.We knew little about the superiority and choice between traditional open and modern arthroscopic techniques.The authors hypothesized that outcomes of all patients will be similar regardless of surgical technique.The patients evaluated on course of this study: 168 patients.The article describes the following procedure: arthroscopy.The devices involved were: unk-implant (lupine and gii anchors).Complications described: one patient in the arthroscopic bankart group and one in the capsular shift group had a postoperative recurrence.The former occurred after 2 years when playing basketball, and the latter was caused by a fall after 17 months.The latarjet group had no recurrence.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = the complaint device is not being returned, the availability of the device unknown, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Multiple attempts were done to obtain more information from the author, however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: correction: the copy of the literature article was inadvertently not attached to the initial report.It has been attached to this medwatch report.

• Brand Name: UNK - IMPLANT
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10837757
• MDR Text Key: 216687734
• Report Number: 1221934-2020-03479
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention