MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, IM ROD, MODULAR; MANUAL INSTR, GENERAL SURGICAL

Model Number	IBALANCE TKA, IM ROD, MODULAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces during use.  as no further investigation was able to be performed no change in harm was identified.  this complaint will be included in trending per (b)(4).
Event or Problem Description
On 5/23/2022, it was reported by a sales representative via (b)(4) that an ar-613-48 modular t-handle broke when surgeon was assembling it to an ar-613-45 im rod.Nothing broke inside the patient and case was completed successfully with another set.This was discovered during a tka procedure on (b)(6) 2022.

• Brand Name: IBALANCE TKA, IM ROD, MODULAR
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19386097
• Report Number: 1220246-2024-03771
• Device Sequence Number: 4020117
• Product Code: LXH
• UDI-Device Identifier: 00888867116467
• UDI-Public: 00888867116467
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: IBALANCE TKA, IM ROD, MODULAR
• Device Catalogue Number: AR-613-45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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