MAUDE Adverse Event Report: ARTHREX, INC. INTBRACE LGMNT REPR AUGMNT KIT; BIO SOFT TISSUE FIXATN FASTNR

Model Number	INTBRACE LGMNT REPR AUGMNT KIT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 28-jan-2026, an arthrex subsidiary employee reported via email that the anchor from an ar-1678-cp internalbrace ligament augmentation repair kit could not be inserted into the bone.The pad was held appropriately, and the screwdriver was turned, but the anchor would not advance.The bone quality was described as hard.No fragments were retained in the patient.The occurrence occurred during a lisfranc ligament reconstruction performed on (b)(6) 2026.The case was completed using a replacement ar-1678-cp kit.There was no significant surgical delay, no additional anesthesia was required, and no adverse effects were reported.No patient harm was identified.

• Brand Name: INTBRACE LGMNT REPR AUGMNT KIT
• 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: 24344217
• Report Number: 1220246-2026-00598
• Device Sequence Number: 18560394
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: 00888867020887
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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 Model Number: INTBRACE LGMNT REPR AUGMNT KIT
• Device Catalogue Number: AR-1678-CP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown