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

Catalog Number	222296
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic rotator cuff repair procedure that the 4.5 healix advance br3sut w/oc anchor device, that the anchor broke.All broken parts were removed.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.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: 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.According to the information provided, it was reported that during the surgery, the anchor was broken (as the photo shows), removed all the broken parts.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The product was not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo found that the device is shown in used condition.Biological matter can be observed on the anchor.The anchor was found cracked at the tip.The overall complaint was confirmed as the observed condition of the 4.5 healix advance br3sut w/oc would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to bending force that was applied and consequently caused the anchor to crack.As per ifu 100191: do not apply a bending force to the inserter.This can damage the anchor or inserter tip.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.Ifu 100191.Device history lot: product code: 222296.Lot no: 263l194.There was a non-conformance nr-0215765/nr-0214787 not related.Manufacturing date: 20-feb-2024.Expiration date: 31-jan-2027.Device history batch: null.Device history review: product code: 222296.Lot no: 263l194.There was a non-conformance nr-0215765/nr-0214787 not related.Manufacturing date: 20-feb-2024.Expiration date: 31-jan-2027.E1: the reporter¿s complete facility address was not 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 ; 9083863534
• MDR Report Key: 24806014
• Report Number: 1221934-2026-01426
• Device Sequence Number: 21502468
• Product Code: MAI
• UDI-Device Identifier: 10886705021321
• UDI-Public: (01)10886705021321(10)263L194(17)270131
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 222296
• Device Lot Number: 263L194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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