MAUDE Adverse Event Report: ARTHREX, INC. GUIDEWIRE, 1.6MM, 4MM BEVELED FT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	GUIDEWIRE, 1.6MM, 4MM BEVELED FT
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
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 (b)(6) 2023, it was reported by a sales representative via sems that a ar-8741-15 guidewire snapped.This occurred during a case, with no patient effect reported.No additional information provided.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
Additional information provided on 01/05/2023, it was reported that a mis bunion case took place on (b)(6) 2022.The device snapped at the junction of the wire driver.The fragments were retrieved, and a different k-wire was used to complete the case.The patient had average bone quality.

• Brand Name: GUIDEWIRE, 1.6MM, 4MM BEVELED FT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16223209
• Report Number: 1220246-2023-06144
• Device Sequence Number: 12413685
• Product Code: LXH
• UDI-Device Identifier: 00888867362376
• UDI-Public: 00888867362376
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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
• Device Catalogue Number: AR-8741-15
• Device Lot Number: 1139856
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown