MAUDE Adverse Event Report: ARTHREX, INC. NITINOL COMPRESSION STAPLE, 9W X 7L; STAPLE, FIXATION, BONE

Model Number	NITINOL COMPRESSION STAPLE, 9W X 7L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/15/2025
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
It was reported that after an initial hallux valgus surgery with an arthrex dynanite staple the patient still has pain in the implant area.No noticeable swelling or redness has occurred.No further information received.

• Brand Name: NITINOL COMPRESSION STAPLE, 9W X 7L
• 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: 23535312
• Report Number: 1220246-2025-05053
• Device Sequence Number: 10167272
• Product Code: JDR
• UDI-Device Identifier: 00888867287853
• UDI-Public: (01)00888867287853(11)230801(17)280731(10)3212133781
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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 Model Number: NITINOL COMPRESSION STAPLE, 9W X 7L
• Device Catalogue Number: AR-8717-0907
• Device Lot Number: 3212133781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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