MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, TIBIAL PREP TRAY, SIZE 6; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IBALANCE TKA, TIBIAL PREP TRAY, SIZE 6
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint confirmed, the bridge of the quick connect feature is broken, but did not break off.The bridge could not be measured due to the damage.A likely cause of the event is user-applied mechanical forces.
Event or Problem Description
On 12/14/2021, it was reported by a facility representative via sems that an ar-623-t6 tibial prep tray and an ar-623-6 keel punch are broken.This was discovered during a procedure.On (b)(6) 2021.

• Brand Name: IBALANCE TKA, TIBIAL PREP TRAY, SIZE 6
• 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: vik bajnath ; 8009337001
• MDR Report Key: 13841188
• Report Number: 1220246-2022-04640
• Device Sequence Number: 17587192
• Product Code: LXH
• UDI-Device Identifier: 00888867214835
• UDI-Public: 00888867214835
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/21/2022

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, TIBIAL PREP TRAY, SIZE 6
• Device Catalogue Number: AR-623-T6
• Device Lot Number: 20641513
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown