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	04/07/2026
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.E1: the reporter¿s complete facility address was not provided.H11: 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
It was reported that during rotator cuff repair surgery, the healix advance orthocord anchor was broken off.All the broken parts were removed.Changed another two devices, one was a healix advance and a gryphon orthocord to continue the surgery but the same problem happened again.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information was provided.This is report 2 of 3 for (b)(4).
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: update: d4, h4: expiration date and device manufacture date have been added, and primary udi number has been updated.

• 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: 25070779
• Report Number: 1221934-2026-01862
• Device Sequence Number: 13445641
• Product Code: MAI
• UDI-Device Identifier: 10886705023479
• UDI-Public: (01)10886705023479(10)287L839(17)270228
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 287L839
• 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: 04/26/2026
• Supplement Date Received by Manufacturer: 05/05/2026; 06/04/2026; 06/09/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/07/2026; 06/05/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown