MAUDE Adverse Event Report: ARTHREX, INC. IBAL TKA FEMORAL IMPACTOR, SOLID HANDLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL TKA FEMORAL IMPACTOR, SOLID HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/18/2023, it was reported by a sales representative via sems that an ar-623-37 femoral impactor plastic is broken.This was discovered during an unspecified time with no patient effect.
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.Upon evaluating the customer's attached picture, it was noted that the instrument's material was severely damaged.The most likely cause of the reported failure is wear and damage due to repeated use and/or reprocessing.The complaint's allegation was confirmed.

• Brand Name: IBAL TKA FEMORAL IMPACTOR, SOLID HANDLE
• 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: 19499687
• Report Number: 1220246-2024-05430
• Device Sequence Number: 6652821
• Product Code: LXH
• UDI-Device Identifier: 00888867229921
• UDI-Public: 00888867229921
• 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): 06/10/2024

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: IBAL TKA FEMORAL IMPACTOR, SOLID HANDLE
• Device Catalogue Number: AR-623-37
• Device Lot Number: 20551618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2016
• 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