MAUDE Adverse Event Report: DePuy Mitek LLC US HEALIX ADVANCE ORTHOCORD; Fastener, fixation, biodegradable, soft tissue

Catalog Number	222324
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	04/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: e1: the reporter¿s facility address was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Event or Problem Description
Post market complication received for re-tears or new tears.Patient id: (b)(6).It was reported that the patient underwent a right rotator cuff repair surgical procedure on (b)(6) 2025.It was reported that a 5.5 healixadv br 5pk-3suture device, and the fms vue ii system and vapr system were used in the procedure.It was reported that the patient suffered re-tears/new tears of the rotator cuff on (b)(6) 2026.It was reported that the patient underwent revision of the rotator cuff on an unknown date.All available information has been disclosed.No additional information could be provided.

• Brand Name: HEALIX ADVANCE ORTHOCORD
• Common Device Name: Fastener, fixation, biodegradable, soft tissue
• Manufacturer (Section D): DePuy Mitek LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50082741
• Report Number: 1221934-2026-03376
• Device Sequence Number: 16015876
• Product Code: MAI
• UDI-Device Identifier: 10886705021529
• UDI-Public: (01)10886705021529(10)9L83154(17)251130
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 222324
• Device Lot Number: 9L83154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male