MAUDE Adverse Event Report: ARTHREX, INC. DRIVER, STAPLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DRIVER, STAPLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the staple driver has a broken tip.It was assumed to have been broken during a surgery.There was no harm for patient, operator or third party reported.No further information was received.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-1005, driver/shaft/handles ns insts, batch number 052344, was received for investigation and upon visual investigation, it was noted that a part of the tip of the device has broken off (see evaluation picture 3).Further the impactor head shows signs of wear and tear (see evaluation picture 4).Functional testing was not performed due to the damage of the device.This is typically caused by wear and tear due to repeated use.

• Brand Name: DRIVER, STAPLE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24321335
• Report Number: 1220246-2026-00543
• Device Sequence Number: 15964912
• Product Code: LXH
• UDI-Device Identifier: 00888867002401
• UDI-Public: (01)00888867002401(11)240308(10)052344
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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): 04/23/2026

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: DRIVER, STAPLE
• Device Catalogue Number: AR-1005
• Device Lot Number: 052344
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown