MAUDE Adverse Event Report: ARTHREX, INC. GUIDEWIRE, 1.6MM, 4MM BEVELED FT, STRL; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GUIDEWIRE, 1.6MM, 4MM BEVELED FT, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
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 during the minimally invasive chevron and akin osteotomies surgery that the guidewire broke while drilling the guidewire for the 4mm beveled screw.The guidewire broke outside the patient in the near to the entrance of the wire attachment.The remaining part of the wire was removed from the patient.The guidewire was drilled with 15.000 rpm.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-8741-15s batch 4155141857 was received for evaluation.Visual inspection revealed that the guidewire was fractured into two separate pieces.One of the segments exhibited a noticeable bend, suggesting possible mechanical stress or damage during use or handling.Functional testing was performed due to the damage to the device.The most likely cause of the reported failure is user error, including excessive force and misalignment of the insertion.

• Brand Name: GUIDEWIRE, 1.6MM, 4MM BEVELED FT, STRL
• 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: 22771139
• Report Number: 1220246-2025-03390
• Device Sequence Number: 13167151
• Product Code: LXH
• UDI-Device Identifier: 00888867362383
• UDI-Public: (01)00888867362383(11)240601(17)290531(10)4155141857
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 09/30/2025

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: GUIDEWIRE, 1.6MM, 4MM BEVELED FT, STRL
• Device Catalogue Number: AR-8741-15S
• Device Lot Number: 4155141857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown