MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 11X10L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 11X10L
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
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 09-feb-2026, an arthrex subsidiary employee reported via email that an ar-8717ds-1110 dynanite nitinol staple implant system had an issue during a procedure performed on (b)(6) 2026.One of the alignment pins included in the kit was identified as being the incorrect thickness and was unable to fit into the drilled holes.As a result, the staples did not provide adequate fixation.The surgeon completed the procedure by using additional k-wires to achieve proper fixation and proceeded with a replacement ar-8717ds-1110 dynanite nitinol staple implant system.There was no significant surgical delay, no additional anesthesia required, and no adverse effects or patient harm reported.Additional information was received on 12-feb-2026: the incorrect staple thickness was first identified during use.The staples that did not provide adequate fixation were left in place.No additional steps were required to achieve fixation, and the procedure was completed using the existing staple and k-wire without the need for a replacement ar-8717ds-1110 dynanite nitinol staple implant system.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 11X10L
• 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: 24470494
• Report Number: 1220246-2026-01065
• Device Sequence Number: 13172613
• Product Code: JDR
• UDI-Device Identifier: 00888867288065
• UDI-Public: (01)00888867288065(11)241201(17)291130(10)4317154532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: DYNANITE NITI STAPLE W/INSTRS 11X10L
• Device Catalogue Number: AR-8717DS-1110
• Device Lot Number: 4317154532
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown