MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE BR3SUT W/OC; 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	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgical procedure, it was discovered that the anchor on the 4.5 healix advance br3sut w/oc device broke off.All the broken parts were removed.It was not reported if there were any delays to the surgical procedure.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: e1: the reporter¿s complete facility address was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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: the product was not returned to depuy synthes; however, a photo was provided for evaluation.Visual inspection of the returned photo found an arthroscopic image of the anchor broken at distal end and cracked vertically from the proximal to the distal end.No other anomalies were noted.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 the procedural variables, such handling of the device or product interaction during procedure, such as off axis insertion and levering during insertion.As per instructions for use (ifu), 1) inserting the awl or drill to less than the specified depth, axial misalignment or levering with the anchor upon insertion may result in anchor fracture.2) do not apply a bending force to the inserter.This can damage the anchor or inserter tip.3) apply tension (normal force) on suture lengths.Excessive force may overload the anchor or suture.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.Device history record review: a device history record review was performed which indicated that there was a non-conformance unrelated to the reported malfunction.All the issues identified were resolved prior to product release.
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, primary udi number and device manufacture date has been added.

• Brand Name: 4.5 HEALIX ADVANCE BR3SUT W/OC
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23568380
• Report Number: 1221934-2025-04406
• Device Sequence Number: 9924678
• Product Code: MAI
• UDI-Device Identifier: 10886705021321
• UDI-Public: (01)10886705021321(10)263L193(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
• Report Date (Section B): 11/17/2025

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: 263L193
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 11/18/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 11/17/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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