MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5HLX ADV PK ANC-DYNA 3-SUT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	222033
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the product has not returned to j&j medtech orthopaedics, however a photo was provided for review.Visual inspection of the returned photo found that the anchor was still attached to the inserter, the anchor had signs of being pulled out of the bone.No other anomalies were noted.The overall complaint was confirmed as the observed condition of 5.5hlx adv pk anc-dyna 3-sut would have contributed to the complained device issue.Device history review: there was no non-conformance regarding this lot.Based on the investigation findings, the potential cause for the reported condition is traced to the procedural variables, such handling of the device or product interaction during procedure, it is possible that the depth penetration of the bone was not maintained; therefore, the anchor did not fully insert, and it was pulled out along with the device.As per the instructions for use, in hard bone, it is necessary to tap the pre-drilled bone hole.Insert the distal tip of the appropriate awl/tap into the pre-drilled hole until the threads are flush with the bone.Rotate the awl/tap in a clockwise direction until the laser line is lush with the bone.Rotate the awl/tap in a counter-clockwise direction to remove.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 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.
Event or Problem Description
It was reported that at the beginning of an unspecified surgical procedure, the sutures are placed in the biceps which are fixed to the humerus by means of a knotless 4.75 healix advance kntls peek anchor device which begins with its respective purple initiator.The device begins to lower the anchor device but there is a lot of tension of the tissue and opens the tip of the anchor preventing it to hold inside the bone.The anchor device was expelled from the bone making it necessary to pass a second knotless suture.A self-drilling 4.9 healix adv sp peek ce device is passed, which remained properly in the bone.The procedure continued with a suture of the rotator cuff, with a 5.5hlx adv pk anc-dyna 3-sut device.The anchor was screwed into the bone, and the sutures were started in the cuff.It was observed that the anchor was expelled from the bone and remained on the outside.The doctor requested a second anchor of the same size, which was placed in a different position in the bone, and functioned properly.At the end of the procedure, the sutures were cut and it was observed that the previously inserted knotless sp anchor, had also been expelled from the bone.It was not reported if there were any delays in a surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.Report 2 of 3 for (b)(4).

• Brand Name: 5.5HLX ADV PK ANC-DYNA 3-SUT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 23020108
• Report Number: 1221934-2025-03407
• Device Sequence Number: 13271329
• Product Code: MBI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• 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: 222033
• Device Lot Number: 105731
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/17/2026; 09/24/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 09/18/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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: N
• Patient Sequence Number: 1
• Patient Sex: Female