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	03/25/2024
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.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.
Event or Problem Description
On 3/25/2024, it was reported by a sales representative via sems-06523645 that an ar-623-36 ibalance tka, tibial impactor and an ar-623-t812 ibalance tka, tibial bearing trial size 8 broke during use with no further information provided.This was discovered during a procedure, with no reported patient harm.Additional information was requested.
Additional Manufacturer Narrative
Complaint has been confirmed.One unpackaged, ar-623-36 / batch: 37622002, tibial impactor, was received for investigation.Visual evaluation found that the tibial impactor's head was cracked.Additionally, the strike cap appears heavily used with dents and marks.Functional testing could not be performed due to the damage of the device.The most likely cause is attributed to misuse due to excessive user-applied mechanical forces.

• 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: 19140599
• Report Number: 1220246-2024-02149
• Device Sequence Number: 7477700
• Product Code: LXH
• UDI-Device Identifier: 00888867229938
• UDI-Public: 00888867229938
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/05/2024

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: 37622002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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