MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP S-TAK,2.4X12MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP S-TAK,2.4X12MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
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 (b)(6) 2025, an arthrex subsidiary employee reported via email an issue involving an ar-1934bcf-24 2.4 mm biocomposite suturetak fracture in half.During the procedure, a 2.4 mm suturetak anchor was requested and placed using standard surgical technique, which included drilling with a 2.4 mm bit and implant impaction.Upon insertion, the implant fractured in half at the anchor.It was noted that a previous implant of the same type had been placed without issue.Prior to placement, the implant stem appeared somewhat unstable; however, insertion was still attempted following all recommended steps.A third implant was subsequently placed and functioned correctly.The incident occurred on 7/14/2025 during a collateral ligament reconstruction procedure.Additional information was received on 08/13/2025: all fragments of the ar-1934bcf-24 2.4 mm biocomposite suturetak were retrieved.The case was completed using a replacement ar-1934bcf-24 from lot number 15044246.No procedural delays were reported, and no additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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.Per dfu-0054-eo - e warnings - 7.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.- g precautions - 5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.The quality of the bone encountered was not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: BIO-COMP S-TAK,2.4X12MM
• 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: 22866245
• Report Number: 1220246-2025-03575
• Device Sequence Number: 18476282
• Product Code: MAI
• UDI-Device Identifier: 00888867023901
• UDI-Public: (01)00888867023901(11)230113(17)261231(10)15044246
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K110660
• 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): 10/30/2025

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: BIO-COMP S-TAK,2.4X12MM
• Device Catalogue Number: AR-1934BCF-24
• Device Lot Number: 15044246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown