MAUDE Adverse Event Report: ARTHREX, INC. SUPERMX NITI STAPLE W/ INSTRS, 18W X 15L; STAPLE, FIXATION, BONE

Model Number	SUPERMX NITI STAPLE W/ INSTRS, 18W X 15L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/23/2024
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 (b)(6) 2024, a patient submitted an inquiry via email requesting the material composition of a 4.5 cannulated screw that was used the procedure.No allegation of product deficiency or adverse event was reported within this inquiry.Additional information received on 11/6/2024: the patient was implanted with two titanium screws and an ar-8719mxds-1815 dynanite supermx nitinol staple.The patient developed complications due to an allergic reaction.The patient underwent revision surgery.No further information has been provided.
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 a patient-specific event.

• Brand Name: SUPERMX NITI STAPLE W/ INSTRS, 18W 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: 20844634
• Report Number: 1220246-2024-08696
• Device Sequence Number: 3758037
• Product Code: JDR
• UDI-Device Identifier: 00888867300873
• UDI-Public: (01)00888867300873(11)190601(17)240531(10)916194436
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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 Expiration Date: 05/31/2024
• Device Model Number: SUPERMX NITI STAPLE W/ INSTRS, 18W X 15L
• Device Catalogue Number: AR-8719MXDS-1815
• Device Lot Number: 916194436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown