MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, DUAL SPIKE PUNCH; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE TKA, DUAL SPIKE PUNCH
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
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 (b)(6) 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Device not expected to return.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause of the failure is use error due to excessive force on the device.
Event or Problem Description
On (b)(6) 2022, it was reported by a distributor via sems that a ar-613-65 dual spike punch is becoming bent where the spikes attach to the base.This was discovered during an unknown time, with no patient effect reported.

• Brand Name: IBALANCE TKA, DUAL SPIKE PUNCH
• 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: 19387755
• Report Number: 1220246-2024-03793
• Device Sequence Number: 20551891
• Product Code: LXH
• UDI-Device Identifier: 00888867116733
• UDI-Public: 00888867116733
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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, DUAL SPIKE PUNCH
• Device Catalogue Number: AR-613-65
• Device Lot Number: 4461409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2014
• 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