MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, PIN DRIVER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE TKA, PIN DRIVER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that part of the pin was broken inside the device.Functional testing was not performed due to the damage to the device.The most likely cause of this condition is attributed to excessive force/friction during use.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-613-91 pin driver broken.This was discovered during a case with no patient effect.Additional information requested.

• Brand Name: IBALANCE TKA, PIN DRIVER
• 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: emily shafer ; 8009337001
• MDR Report Key: 17248198
• Report Number: 1220246-2023-07042
• Device Sequence Number: 4872315
• Product Code: LXH
• UDI-Device Identifier: 00888867116900
• UDI-Public: 00888867116900
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 07/03/2023

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, PIN DRIVER
• Device Catalogue Number: AR-613-91
• Device Lot Number: 1391742
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown