MAUDE Adverse Event Report: ARTHREX, INC. GUIDE WIRE INSERTER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	GUIDE WIRE INSERTER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to wear and tear.
Event or Problem Description
It was reported on 10/14/2022 by a sales representative via sems that an ar-8973-13 guide wire inserter was malfunctioning non-specifically.Per facility: "in the case when the surgeon was using it, the handpiece was sliding up and down and came off.Didn't let the surgeon use it correctly".This was discovered during a case with no patient harm.

• Brand Name: GUIDE WIRE INSERTER
• 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: 19247980
• Report Number: 1220246-2024-02808
• Device Sequence Number: 7351444
• Product Code: LXH
• UDI-Device Identifier: 00888867302501
• UDI-Public: 00888867302501
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: GUIDE WIRE INSERTER
• Device Catalogue Number: AR-8973-13
• Device Lot Number: 37982133
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown