MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø10X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
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 10/13/2025, it was reported by an arthrex subsidiary employee via email that an ar-4030c-10 fastthread biocomposite interference screw fractured during tibial fixation.The surgeon was able to insert approximately half of the screw using the screwdriver, but it would not advance further.Upon removing the screwdriver, the screw was found to be fractured.This issue was discovered during a procedure performed on (b)(6) 2025.
Event or Problem Description
Additional information was received on 10/20/2025: this issue occurred during an acl reconstruction and meniscal repair procedure on (b)(6) 2025.The anchor remained in the patient, and the fragments were retrieved.The procedure was completed using a replacement ar-4030c-10 fastthread biocomposite interference screw from lot number 15156623.The case proceeded without delay, and no additional anesthesia was required.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically improper bone preparation and failure to fully seat the screwdriver in the screw, as noted on dfu-0111-eor3_fmt_en, interference screws, section g.Precautions: 6.Bio-absorbable interference screw only: it is important to completely seat the screwdriver to prevent potential stripping of the hex and/or screw fracture during insertion or removal.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: Ø10X 30MM BC IF SCRW, VENTED
• 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: 23322260
• Report Number: 1220246-2025-04663
• Device Sequence Number: 21309630
• Product Code: MAI
• UDI-Device Identifier: 00888867277670
• UDI-Public: (01)00888867277670(11)250311(17)290228(10)15403103
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K202535
• 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,Followup
• Report Date (Section B): 02/18/2026

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: Ø10X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-10
• Device Lot Number: 15403103
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: Not provided; 02/16/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 10/29/2025; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown