MAUDE Adverse Event Report: ARTHREX, INC. KEEL PUNCH, SIZE 4-7, IBALANCE TKA; ORTHOPEDIC MANUAL SURG INSTR

Model Number	KEEL PUNCH, SIZE 4-7, IBALANCE TKA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
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 04/04/2024, it was reported by a sales representative via (b)(4) that an ar-623-6 keel punch top section broke off during impaction.This occurred during use in a case with no patient effect.Case completed using another punch.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is confirmed.Based on the images provided from the field, the device appears to have a broken fragment.Consequently, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to excessive user-applied mechanical forces.

• Brand Name: KEEL PUNCH, SIZE 4-7, IBALANCE TKA
• 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: 19201631
• Report Number: 1220246-2024-02536
• Device Sequence Number: 8048808
• Product Code: LXH
• UDI-Device Identifier: 00888867198371
• UDI-Public: 00888867198371
• 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): 06/12/2025

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: KEEL PUNCH, SIZE 4-7, IBALANCE TKA
• Device Catalogue Number: AR-623-6
• Device Lot Number: 20641511
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2015
• 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