MAUDE Adverse Event Report: ARTHREX, INC. Ø10 X 30MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number	Ø10 X 30MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2025
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, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-4030p-10 fastthread¿ peek interference screw 10x30 did not achieve proper fixation and had to be replaced with a larger size (11x30) due the patient's bone quality.It was further reported that during the surgery, the surgeon was unable to locate the flexor tendons to reconstruct the acl and instead harvested the quadriceps tendon.As a result, the acl reconstruction surgery was delayed by two hours and required additional anesthesia.Additional information provided 29-dec-2025: it was confirmed that there was no device breakage.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of surface damage of an ar-4030p-10 batch 15374763.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors, as the initial 10 × 30 interference screw did not achieve adequate fixation due to poor bone quality, and fixation was successfully achieved after upsizing to a larger screw.

• Brand Name: Ø10 X 30MM PEEK IF SCRW NON-VENTED
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23943329
• Report Number: 1220246-2026-00009
• Device Sequence Number: 18830927
• Product Code: MAI
• UDI-Device Identifier: 00888867295070
• UDI-Public: (01)00888867295070(11)250117(17)291231(10)15374763
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 04/20/2026

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: Ø10 X 30MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4030P-10
• Device Lot Number: 15374763
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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