MAUDE Adverse Event Report: ARTHREX, INC. TIBIAL RESECTION GUIDE CONNECTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TIBIAL RESECTION GUIDE CONNECTOR
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while prepping tibial resection the nut on the ar-623-38 would not loosen up and is still stuck.See source data and image attached.
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 event could not be verified with the pictures provided.Based off the information provided, the most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(6).

• Brand Name: TIBIAL RESECTION GUIDE CONNECTOR
• 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: 19561957
• Report Number: 1220246-2024-06000
• Device Sequence Number: 15354894
• Product Code: LXH
• UDI-Device Identifier: 00888867249813
• UDI-Public: 00888867249813
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/18/2024

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: TIBIAL RESECTION GUIDE CONNECTOR
• Device Catalogue Number: AR-623-38
• Device Lot Number: 37621633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown