MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE NITI STAPLE W/INSTRS 9WX7L; STAPLE, FIXATION, BONE

Model Number	DYNANITE NITI STAPLE W/INSTRS 9WX7L
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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 11/18/2025, an arthrex subsidiary employee reported via email that the drill bit in the ar-8717ds-0907 dynanite nitinol staple implant system could not be removed from the sleeve.The case was completed with a replacement ar-8717ds-0907 dynanite nitinol staple implant system.There was no detailed information on the type of surgery.There was no significant delay, no additional anesthesia was administered, and no adverse effects were reported.No photos were taken of the event.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 11/21/2025: this issue occurred after the bone holes had been created.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is not confirmed.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 of the reported failure can be attributed to a manufacturing issue due to interference, improper seating, or internal obstruction within the sleeve during extraction: however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: DYNANITE NITI STAPLE W/INSTRS 9WX7L
• 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: 23742159
• Report Number: 1220246-2025-05461
• Device Sequence Number: 8460579
• Product Code: JDR
• UDI-Device Identifier: 00888867287846
• UDI-Public: (01)00888867287846(11)240301(17)290228(10)4060139220
• 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,Followup
• Report Date (Section B): 05/18/2026

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 9WX7L
• Device Catalogue Number: AR-8717DS-0907
• Device Lot Number: 4060139220
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/09/2026; 05/15/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/13/2026; 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown