MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX ADVANCE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222331
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
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: the product was not returned to depuy synthes; however, a photo was provided for evaluation.Visual inspection of the returned photo found that the anchor was attached to the inserter, just as it was broken at distal end.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the 5.5 healix advance kntlss br would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to off axis insertion and levering during insertion.As per the instruction for use, ensure that anchor is inserted axially to the bone hole (limit off-axis insertion).Improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture or reduced performance.Properly handling and attention to the approved use of the device diminishes the risk of failure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.There was no non-conformance regarding this lot 261l022.E1: the reporter¿s complete facility address was not provided.
Event or Problem Description
It was reported that during the arthroscopy surgery with a 5.5 healix advance kntlss br , the anchor was broke off.They removed all the broken parts.Another device was used to complete the surgery.There were no adverse consequences to the patient or procedure delay.No additional information could be provided.
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.

• Brand Name: HEALIX ADVANCE
• 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 ; 9083863534
• MDR Report Key: 25049636
• Report Number: 1221934-2026-01813
• Device Sequence Number: 10370215
• Product Code: MAI
• UDI-Device Identifier: 10886705023479
• UDI-Public: (01)10886705023479(10)261L022(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 222331
• Device Lot Number: 261L022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 05/14/2026; 05/15/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/15/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown