MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/05/2022, it was reported by a distributor via (b)(4) that a ar-613-1 keel punch handle is cracked, declaring the device unusable for use.This was discovered during an unknown time with no patient effect reported.
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.Complaint confirmed.Visual investigation noticed the handle has nicks around it and the tip of the impactor sleeve is damaged.The most likely cause of the reported failure is use error.

• Brand Name: IBALANCE TKA, HANDLE, MODULAR KEEL 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: 19383719
• Report Number: 1220246-2024-03756
• Device Sequence Number: 17875749
• Product Code: LXH
• UDI-Device Identifier: 00888867115941
• UDI-Public: 00888867115941
• 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: 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, HANDLE, MODULAR KEEL PUNCH
• Device Catalogue Number: AR-613-1
• Device Lot Number: 1391632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2016
• 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