MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HEALIX ADVANCE BR ANCHOR W/DYNACORD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
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.H11 additional narrative: e1: the reporter¿s complete facility address was not provided.Investigation summary 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.The anchor was found cracked.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the 4.5hlx adv br anc-dyna str/bl would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to axial misalignment during insertion.As per the instructions for use (ifu); 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.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.
Event or Problem Description
It was reported that during a rotator cuff repair surgical procedure, while using the 4.5hlx adv br anc-dyna str/bl device, it was observed that the anchor was broken off.It was reported that the surgeon changed to another 4.5hlx adv br anc-dyna str/bl device to continue the surgery, the same problem happened again.It was reported that all broken parts were removed from the patient.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.This is report 2 of 2 for (b)(4).

• Brand Name: HEALIX ADVANCE BR ANCHOR W/DYNACORD
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24988398
• Report Number: 1221934-2026-01674
• Device Sequence Number: 9642106
• Product Code: MAI
• UDI-Device Identifier: 10886705029402
• UDI-Public: (01)10886705029402(10)240L536(17)260930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173859
• 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

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 222001
• Device Lot Number: 240L536
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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