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

Model Number	IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
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.Complaint is confirmed.Functional testing was not performed on the returned ar-613-1 due to the damage to the handle of the device.Visual evaluation noted that the handle is cracked.The most likely cause is attributed to misuse due to applying excessive forces.Refer to investigation photo.
Event or Problem Description
On 12/07/2022 it was reported by a sales representative via sems that a ar-613-1 ibalance¿ tka handle was cracked.This was discovered during a case on (b)(6) 2022.Another set and handle were used to complete the case.There was no patient effect reported.

• Brand Name: IBALANCE TKA, HANDLE, MODULAR KEEL PUNCH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 19457195
• Report Number: 1220246-2024-04803
• Device Sequence Number: 6652921
• Product Code: LXH
• UDI-Device Identifier: 00888867115941
• UDI-Public: 00888867115941
• 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): 06/04/2024

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: 051947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown