MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.5HLX ADV BR ANC-DYNA 3-SUT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 222002

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

Patient Problems Inflammation (1932); Unspecified Tissue Injury (4559)

Event Date 08/03/2023

Event Type  Injury  

Event Description

This is report 2 of 2 for (b)(4).It was reported by a healthcare professional through clinical research that during a rotator cuff repair procedure of the right shoulder on (b)(6) 2022 due to a recurrent rotator cuff tear with severe bicipital tenosynovitis, a 4.75 healix advance kntls br device and a 4.5hlx adv br anc-dyna 3-sut device were used.According to the report, a shoulder arthroscopy with revision rotator cuff repair was performed on (b)(6) 2023 with a double row approach with multiple lock sutures.It was further reported that the revision procedure included an arthroscopic limited debridement including removal of retained and previous suture material.The status of the patient was unknown.No additional information was provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.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.H10 additional narrative: udi: (b)(4).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.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device, and no non-conformance was identified.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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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: b5: additional information was received on (b)(6) 2024: there was a re-operation/revision event details: event date: (b)(6) 2023 alert date: (b)(6) 2024 event occurred country of event: united states procedure 1: rotator cuff repair date of surgery: (b)(6)2022 patient details patient identifier: male age (at time of consent): 55 years operative side: right surgeon first name: paul surgeon last name: favorito was the fms vue ii system used for this procedure? : no was the vapr system used for this procedure? : no was the speedtrap graft preparation system used for this procedure? : no additional event details re-op/revision procedure - other, specify 1: shoulder arthroscopy with revision rotator cuff repair with a double row approach with multiple lock sutures.Arthroscopic limited debridement including removal of retained and previous suture material re-op/revision procedure 2: other re-op/revision procedure - other, specify 2: debridement of the superior labrum and revision release of adhesions from the subacromial space re-op/revision procedure 3: biceps tenodesis re-op/revision procedure - other, specify 3: unknown was the fms vue ii system used for this procedure? : value "blank" has been changed to "no" was the speedtrap graft preparation system used for this procedure? : value "blank" has been changed to "no" was the vapr system used for this procedure? : value "blank" has been changed to "no".

• Brand Name: 4.5HLX ADV BR ANC-DYNA 3-SUT
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18155356
• MDR Text Key: 328354458
• Report Number: 1221934-2023-04231
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705029396
• UDI-Public: 10886705029396
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 222002
• Device Lot Number: 9L45434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male