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	08/26/2024
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
It was reported by a sales representative that an ar-1249 nitinol guide pin for bio-interference screws had a 2 inch piece of the nitinol guidewire break off in the patient.The case was completed without further information on whether the broken nitinol guidewire had been retrieved from the patient.The rep was unaware of this event in the case, the current status of the patient, and the whereabouts of the nitinol wire.This occurred during an acl reconstruction and meniscus repair procedure on (b)(6) 2024.
Event or Problem Description
Additional information has been received on 09/10/2024: there is no revision surgery planned.The wire broke when implanting the screw correctly, and no additional products were used to complete the case, with no change in the technique.The case was delayed 5-10 minutes with no additional anesthesia administered.It is unknown if the patient experienced any adverse effects.There was no report of medical intervention or hospitalization needed due to this issue.Additional information was received on 09/16/2024: the rep confirmed via email that the 2-inch nitinol guidewire was retrieved from the patient.
Additional Manufacturer Narrative
Additional information: 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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 20200851
• Report Number: 1220246-2024-07565
• Device Sequence Number: 6674436
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2025

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: NIT G-PIN. BIO-INTERF SCRW 1.1MM
• Device Catalogue Number: AR-1249
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 06/09/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/19/2024; 07/02/2025
• 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