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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/7/2024, it was reported by a sales representative via (b)(4) that an ar-623-6 keel punch and an ar-623-37 ibal tka femoral impactor had an issue.The ar-623-6 keel punch connection had been worn, making it difficult to attach to other instruments.Another instrument was used to remove the instrument.Upon completion of the case and during the inspection of instruments, it was noticed that the ar-623-37 ibal tka femoral impactor had sustained a crack.No second surgery is needed, and no patient harm was noted.This was discovered during a tka procedure on (b)(6) 2024.Additional information was received on 3/11/2024: no pieces broke in the patient.There was no case delay.It is unknown what product was used to complete the case.
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.
Additional Manufacturer Narrative
Additional info: g.3 the complaint is confirmed.One unpackaged ar-623-37 / batch: 37622001 was received for investigation.Visual evaluation noted that the femoral impactor head has a crack.Additionally, various marks were observed on the strike cap that were incurred over repeated usage.Functional testing wasn't performed due to the damage of the device.The most likely cause for the reported failure is attributed to misuse due to excessive user-applied mechanical forces.

• 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: 18960553
• Report Number: 1220246-2024-01642
• Device Sequence Number: 12802164
• Product Code: LXH
• UDI-Device Identifier: 00888867229921
• UDI-Public: 00888867229921
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/21/2024

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: 37622001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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