MAUDE Adverse Event Report: ARTHREX, INC. GUIDEWIRE, 1.6X150MM, CAPITAL FRAG; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GUIDEWIRE, 1.6X150MM, CAPITAL FRAG
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/14/2023
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 4/14/2023, it was reported by an arthrex employee via email that during an office visit, the doctor mentioned that an arthrex tool used for surgeries gets too hot that it leaves a burn mark, "like a brand," on his patients.No further information was provided.Additional information received on 4/19/2023: part number ar-8741-14 guidewire, 1.4 mm, for 3.5 mm and ar-8741-16 capital fragment guidewire 1.6mm were provided.Additional information received on 4/19/2023: per the sales representative that was present during the procedure, this was a mis bunion surgery, the exact date is unknown.It is also unknown which part ar-8741-14 or ar-8741-16 caused the patient's burn.Additional information requested.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.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 misaligned insertion; prying/leveraging the device and excessive force applied during insertion.

• Brand Name: GUIDEWIRE, 1.6X150MM, CAPITAL FRAG
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16906729
• Report Number: 1220246-2023-06709
• Device Sequence Number: 12467286
• Product Code: LXH
• UDI-Device Identifier: 00888867362390
• UDI-Public: 00888867362390
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GUIDEWIRE, 1.6X150MM, CAPITAL FRAG
• Device Catalogue Number: AR-8741-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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