MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR T-HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBALANCE TKA, MODULAR T-HANDLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that a ar-613-48 t-handle cracked in half.This occurred during a tka procedure, all fragments were retrieved.The case was completed, with no patient effect reported.
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
Complaint confirmed.One unpackaged ar-613-48 was received for investigation.Visual inspection identified that the c8573-01 t-handle had cracked and split into two pieces, separating from the c8574-01 t-handle shaft.Based on the age and returned condition of the device, a likely cause is attributed to wear and tear damage accumulated over repeated usage.

• Brand Name: IBALANCE TKA, MODULAR T-HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14915134
• Report Number: 1220246-2022-05182
• Device Sequence Number: 2033273
• Product Code: LXH
• UDI-Device Identifier: 00888867116498
• UDI-Public: 00888867116498
• 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): 07/29/2022

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: IBALANCE TKA, MODULAR T-HANDLE
• Device Catalogue Number: AR-613-48
• Device Lot Number: 67251332
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown