MAUDE Adverse Event Report: ARTHREX, INC. NIT G-PIN. BIO-INTERF SCRW 1.1MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	NIT G-PIN. BIO-INTERF SCRW 1.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/05/2025, it was reported by a sales representative via (b)(4) that an ar-1249 nit g-pin.Bio-interf scrw 1.1mm wire broke off at the end inside the patient.This was part of ar-1898s disps kit, trans-tib acl w/o sawbld.This was discovered during an acl reconstruction.The piece was removed and the case was completed with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 such as misaligned insertion, prying, and leveraging the device with excessive force.

• Brand Name: NIT G-PIN. BIO-INTERF SCRW 1.1MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 23645923
• Report Number: 1220246-2025-05185
• Device Sequence Number: 14678325
• Product Code: MDM
• UDI-Device Identifier: 00888867006164
• UDI-Public: 00888867006164
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: NIT G-PIN. BIO-INTERF SCRW 1.1MM
• Device Catalogue Number: AR-1249
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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