MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX NITI STAPLE W/ INSTRS, 15W X 15L; STAPLE, FIXATION, BONE

Model Number	SUPERMX NITI STAPLE W/ INSTRS, 15W X 15L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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
On (b)(6) 2024, it was reported by a sales representative via email that the drill from an ar-8719mxds-1515 dynanite supermx nitinol staple would not advance through the guide.The surgeon stopped drilling and noted that the drill and guide could not be taken apart.The guide ended up breaking in half and the drill was still inside the guide.This was discovered during a second and third tarsometatarsal arthrodesis procedure on (b)(6) 2024.Additional information received on 1/6/2025: the guide broke while it was in the patient; however, there were no loose fragments in the patient and the surgeon was able to remove the broken drill guide and bit safely.The case was completed by opening another ar-8719mxds-1515 dynanite supermx nitinol staple.The case was delayed five minutes without additional anesthesia.
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 device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely cause of the reported failure is excessive side-loading forces applied to the drill during use.The complaint allegation was confirmed based on the customer's attached photo, which shows the drill guide missing a piece and the drill with the detached metal piece still attached.

• Brand Name: SUPERMX NITI STAPLE W/ INSTRS, 15W X 15L
• Common Device Name: STAPLE, FIXATION, BONE
• 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: 21168160
• Report Number: 1220246-2025-09484
• Device Sequence Number: 21185354
• Product Code: JDR
• UDI-Device Identifier: 00888867300866
• UDI-Public: (01)00888867300866(11)240701(17)290630(10)4165150068
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K203180
• 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): 09/10/2025

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: SUPERMX NITI STAPLE W/ INSTRS, 15W X 15L
• Device Catalogue Number: AR-8719MXDS-1515
• Device Lot Number: 4165150068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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