MAUDE Adverse Event Report: ARTHREX, INC. SPKD LGMNT STAPLE,8 MMX 20 MMMED; STAPLE, FIXATION, BONE

Model Number	SPKD LGMNT STAPLE,8 MMX 20 MMMED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2025
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
It was reported that during a surgery the device broke during the implantation.No further information received.

• Brand Name: SPKD LGMNT STAPLE,8 MMX 20 MMMED
• 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: 23381247
• Report Number: 1220246-2025-04816
• Device Sequence Number: 17375412
• Product Code: JDR
• UDI-Device Identifier: 00888867002494
• UDI-Public: (01)00888867002494(11)250124(17)291130(10)T250761
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K943492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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: SPKD LGMNT STAPLE,8 MMX 20 MMMED
• Device Catalogue Number: AR-1008
• Device Lot Number: T250761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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
• Patient Sex: Unknown