MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, SMALL IMPACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE TKA, SMALL IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/15/2022, it was reported by a sales representative via (b)(4) that qty.2 of an ar-613-98 ibalance¿ tka, small impactor had an issue.The surgeon was doing a tka on (b)(6) 2022 and while using the small impactor the tip broke off of two of them.They opened another instrument set and got another one to finish the case with.That one worked and the case was finished without further incident.This was discovered during use with no impact to the patient.Additional information has been requested.On 04/26/2022, the sales representative stated the following information via phone: the two complaint devices split in half and broke outside of the patient, fell on the floor, and all fragments were retrieved.The bone quality of the patient was not provided.
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.

• Brand Name: IBALANCE TKA, SMALL IMPACTOR
• 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: 19402339
• Report Number: 1220246-2024-04007
• Device Sequence Number: 12456588
• Product Code: LXH
• UDI-Device Identifier: 00888867116955
• UDI-Public: 00888867116955
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/27/2024

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, SMALL IMPACTOR
• Device Catalogue Number: AR-613-98
• Device Lot Number: 11360942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/27/2024
• 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