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

Model Number	IBAL TKA TIBIAL IMPACTOR, SOLID HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
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.Complaint confirmed.Visual evaluation of the device shows the tibial impactor head split in half.Split occurred in the middle of the part, in the cavity that surrounds the shaft pin.The strike cap appears heavily used with dents and marks.The handle also shows signs of wear.The most likely cause of the reported failure is wear and tear.
Event or Problem Description
On 07/28/2022, it was reported by a sales representative via sems that an ar-623-36 ibal tka tibial impactor, solid handle, was broken.This occurred during a tka procedure, no piece broke off inside the patient, and no broken piece needed to be retrieved.The procedure was completed successfully.This was discovered during use with no impact to the patient.Additional information has been requested.On 08/05/2022, the sales representative stated the following information via phone: the blue top part of the handle cracked and split down the middle outside of the patient, nothing broke off or fell apart.That part of the procedure was completed, the bone quality of the patient was not provided and the device was available for return.

• Brand Name: IBAL TKA TIBIAL 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: 19352489
• Report Number: 1220246-2024-03526
• Device Sequence Number: 7109700
• Product Code: LXH
• UDI-Device Identifier: 00888867229938
• UDI-Public: 00888867229938
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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 TIBIAL IMPACTOR, SOLID HANDLE
• Device Catalogue Number: AR-623-36
• Device Lot Number: 37621931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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