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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/20/2025, an arthrex subsidiary employee reported via email that an issue occurred with the ar-1678-cp internalbrace ligament augmentation repair kit during a procedure.While drilling into the fibula using the 2.7 mm hollow drill through the drill guide, a metal fragment-like object was found attached to the drill.The surgeon inspected the drill guide but found no foreign material present.No fragments were reported to be retained in the patient.The procedure was completed using a replacement ar-1678-cp kit.No detailed information was provided regarding the type of surgery.There was no significant delay, no additional anesthesia administered, and no adverse effects reported.Additionally, no photographs were taken of the event.The issue was identified during a procedure on (b)(6) 2025, with no patient harm reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.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 failure can be attributed to user error, of the device coming in contact with another device during use.

• 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: 23415132
• Report Number: 1220246-2025-04875
• Device Sequence Number: 21434567
• Product Code: MAI
• UDI-Device Identifier: 00888867020887
• UDI-Public: (01)00888867020887(11)250523(17)270430(10)15440732
• 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): 03/03/2026

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
• Device Lot Number: 15440732
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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
• Patient Sex: Unknown