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

Catalog Number	222295
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery the shaft of the 4.5 healix advance br w/ocord device was bent and deformed.It was reported that a spare device was used to complete the surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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: investigation summary a photo of the product was provided to depuy synthes for evaluation, and an investigation was conducted in accordance with depuy synthes procedures.Visual inspection of the photo found that the device is shown in used condition.The inserter tip was found slightly bent.No other anomalies were found.The reported complaint was confirmed based on the evaluation results.The investigation traced the potential cause to bending force applied to the inserter during insertion and consequently caused the inserter tip bending.It has been determined that no corrective or preventive actions are proposed.There is no indication that a design or manufacturing issue caused the reported condition.As part of depuy synthes quality processes, all devices are manufactured, inspected, and released in accordance with approved specifications.Additional monitoring for potential safety signals is conducted through complaint trend analysis as part of post-market safety surveillance activities.Device history review: there was no non-conformance regarding this lot.

• 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: 50933813
• Report Number: 1221934-2026-04440
• Device Sequence Number: 10722306
• Product Code: MAI
• UDI-Device Identifier: 10886705021314
• UDI-Public: (01)10886705021314(10)10ABZB(17)280731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 222295
• Device Lot Number: 10ABZB
• 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: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2025
• 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