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 Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 03/6/2024, it was reported by a sales representative via (b)(4) that an ar-623-36 ibalance tka, tibial impactor plastic piece split into two pieces.This was when the surgeon was impacting the tibial component.Nothing broke inside the patient.This was discovered during a total knee procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpacked ar-623-36 with serial/batch number (b)(6) was received for investigation.Upon visual evaluation, it was noted that the head of the device was broken into two parts.The reported condition is most likely caused by overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.The device was manufactured in 2019.

• 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: 18945491
• Report Number: 1220246-2024-01584
• Device Sequence Number: 12739278
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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 TIBIAL IMPACTOR, SOLID HANDLE
• Device Catalogue Number: AR-623-36
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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