MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, PEEK, NON-COLLAGEN COATED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IB KIT, PEEK, NON-COLLAGEN COATED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial surgery in which an ar-8991 was used, the knotless fibertak suture was pulled out of an open wound that would not heal.Part of the device remained inside the patient.No further information received.***update 14-jan-2026.It was further reported that the original surgery was performed on the 10th of november 2025 and the revision surgery was performed on the (b)(6) 2026.Nothing was removed until the first check-up, where the surgeon pulled some suture out of the wound which wasn't healing.The patient was then scheduled for the second surgery to remove the anchors and tape/sutures properly.The patient was young and, in this period, had healed enough to be stable and didn't need any further implants.***update 22-jan-2026.It was further reported that the surgeon also used the device ar-1778p-cp on the patient, which was removed from the patient on the (b)(6) 2026.
Additional Manufacturer Narrative
Complaint allegation is confirmed by the attached picture, which shows the eyelet, anchor and pieces of sutures removed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported issue is a patient-specific postoperative event resulting in exposure and migration of suture material through a non-healing surgical wound, which led to partial externalization of the knotless fibertak® suture.Residual anchor and suture material remained implanted until the revision procedure, at which time the devices were removed once the patient had healed sufficiently and no longer required additional fixation.

• Brand Name: IB KIT, PEEK, NON-COLLAGEN COATED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24307293
• Report Number: 1220246-2026-00508
• Device Sequence Number: 9679749
• Product Code: MAI
• UDI-Device Identifier: 00888867318120
• UDI-Public: 00888867318120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: IB KIT, PEEK, NON-COLLAGEN COATED
• Device Catalogue Number: AR-1778P-CP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown