MAUDE Adverse Event Report: ARTHREX, INC. .045" GUIDE WIRE TROCAR TIP; ARTHROSCOPIC ACCESSORIES

Model Number	.045" GUIDE WIRE TROCAR TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/28/2025
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 mtp arthrodesis surgery during insertion of the second 3,5 comp ft screw the tip of the k-wire became bend (k-wire was inserted into the lateral cortex but not through).When the surgeon checked the position of the screw on the x-ray the bended k-wire must be hidden behind the screw so everything looked fine.The customer then drilled and over drilled with the right instruments for the screw.Right after that the customer broke the tip of the k-wire when they were taking it out with a drill.Small part of the k-wire remained in the screw inserted in the bone and the other bent part of the k-wire was visible on the x-ray in the bone.The surgeon left the piece of the k-wire inside the bone because there were no chance to remove it.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: 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 for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: .045" GUIDE WIRE TROCAR TIP
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 21365537
• Report Number: 1220246-2025-00407
• Device Sequence Number: 8416479
• Product Code: NBH
• UDI-Device Identifier: 00888867127197
• UDI-Public: (01)00888867127197(11)240716(10)4156141896
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: .045" GUIDE WIRE TROCAR TIP
• Device Catalogue Number: AR-8737-41
• Device Lot Number: 4156141896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• 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