MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, TROCAR PIN SMOOTH; MANUAL INSTR, GENERAL SURGICAL

Model Number	IBALANCE TKA, TROCAR PIN SMOOTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/13/2021, it was reported by a sales representative via e-mail that an ar-611dr07 and ar-613-50 instrument broken.This was discovered during a uni knee arthroplasty on (b)(6) 2021.The ar-613-50 broke off inside pin hole of item ar-611dr07.Device was removed and the case was completed by using a new ar-611dr07 and ar-613-50.
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 error of the device due to user-applied mechanical forces during use.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per wi-000100100.

• Brand Name: IBALANCE TKA, TROCAR PIN SMOOTH
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19331379
• Report Number: 1220246-2024-03402
• Device Sequence Number: 20560615
• Product Code: MDM
• UDI-Device Identifier: 00888867116542
• UDI-Public: 00888867116542
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/16/2024

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, TROCAR PIN SMOOTH
• Device Catalogue Number: AR-613-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown