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	Foreign Body In Patient (2687)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/09/2025, it was reported by a sales representative via phone that an ar-1249 nitinol guide pin for bio-interference screws broke.This was discovered a week after undergoing an acl reconstruction on (b)(6) 2025.The patient was experiencing pain and went in for a follow-up.An x-ray confirmed there was a fragment in the patient's knee.The revision procedure has taken place and the fragment was removed.
Additional Manufacturer Narrative
Additional information: b3, g3, h3, h6.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 for the reported failure can be attributed to use error.The dfu for this device, dfu-0023-eo revision 4, gives the following warning: 2.After insertion of the instrument into the joint, do not apply additional flexion to the joint.A piece of a broken instrument can become lodged in soft tissue and/or disappear from the arthroscopic view of the surgical field resulting in possible fragments being retained in the patient.

• 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: 21979213
• Report Number: 1220246-2025-01941
• Device Sequence Number: 13016126
• Product Code: MDM
• UDI-Device Identifier: 00888867006164
• UDI-Public: (01)00888867006164(11)231128(10)15173041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NIT G-PIN. BIO-INTERF SCRW 1.1MM
• Device Catalogue Number: AR-1249
• Device Lot Number: 15173041
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown