MAUDE Adverse Event Report: ARTHREX, INC. NITINOL COMPRESSION STAPLE, 9W X 10L; STAPLE, FIXATION, BONE

Model Number	NITINOL COMPRESSION STAPLE, 9W X 10L
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 03/22/2024, it was reported by a sales representative via email that an ar-8717-0910 dynanite nitinol staple pulled through and appeared to crumble the bone.The case was completed by removing the staple and pinning the patient's toe with a k-wire.This was discovered during a first phalangeal akin osteotomy procedure on (b)(6) 2024.
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 can be attributed to misaligned insertion; or prying/leveraging the device during use.

• Brand Name: NITINOL COMPRESSION STAPLE, 9W X 10L
• 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: 19139575
• Report Number: 1220246-2024-02141
• Device Sequence Number: 9438431
• Product Code: JDR
• UDI-Device Identifier: 00888867287921
• UDI-Public: 00888867287921
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 06/09/2025

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 10L
• Device Catalogue Number: AR-8717-0910
• Device Lot Number: 3205133575
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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