MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.5HLX ADV BR ANC-DYNA STR/BL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	222001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a rotator cuff repair procedure for right shoulder cuff injury, it was observed that while using the 4.5hlx adv br anc-dyna str/bl device, two anchors were placed at the greater tuberosity of the humerus to fix the torn supraspinatus, and the operation was completed successfully.It was reported that post surgery, three days later, an mri of the right shoulder revealed anchor loosening and a failure of implant fixation was considered.According to the reporter, the next day, a "right rotator cuff repair" was performed under general anesthesia and during the operation one anchor was loosened and detached, which was removed, and then one anchor was re-placed in the footprint area of greater tuberosity of humerus to fix the superior muscle on the stop point of greater tuberosity.It was reported that the operation went smoothly, and the right upper limb cervico-wrist band was immobilized after the operation.No additional information can be provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11: additional narrative: device history review: there was a non-conformance not related.The complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (242l950), and there was a non-conformance unrelated to the reported complaint.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11: additional narrative: additional information was received stating that the surgeon reported that the cause of anchor pullout after the surgery was related to the patient's postoperative bath.During the second surgery, it was found that the cortical bone at the anchor implantation site was cracked and the anchor was bent and broken.The patient was stable after the second procedure and no further adverse events were reported.

• Brand Name: 4.5HLX ADV BR ANC-DYNA STR/BL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 23368991
• Report Number: 1221934-2025-03960
• Device Sequence Number: 13284124
• Product Code: MAI
• UDI-Device Identifier: 10886705029402
• UDI-Public: (01)10886705029402(10)242L950(17)261031
• 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
• Report Date (Section B): 10/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 222001
• Device Lot Number: 242L950
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown