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

Catalog Number	222296
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a rotator cuff repair surgical procedure, when the packaging for the 4.5 healix advance br3sut w/oc anchor device was opened, it was observed that the anchor was broken off.It was reported that another device was used to complete the surgery.There were no adverse consequences to the patient.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.H11 additional narrative: e1: the reporter¿s complete facility address was not provided.Investigation summary the product has not returned to depuy synthes, however a photo was provided for evaluation.Visual inspection of the returned photo found the device sitting in the desiccating tray.The anchor was cracked at the distal end.The handle had foreign matter, presumably biological residue.As the device show signs of use, the reported complaint of failure without use cannot be confirmed.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 condition showed in the photo, we cannot definitively determine whether the issue occurred due to the device manipulation signs found.Therefore, this event is undetermined.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.

• 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: 25023239
• Report Number: 1221934-2026-01751
• Device Sequence Number: 9175930
• Product Code: MAI
• UDI-Device Identifier: 10886705021321
• UDI-Public: (01)10886705021321(10)263L196(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): 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: 222296
• Device Lot Number: 263L196
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 06/10/2026; 06/16/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/11/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown