MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 3 8MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA TIB BEA-RING TRL SZ 3 8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported on (b)(6) 2023, by a sales representative via sems that an ar-601-tbc8 tibial bearing part broke off during uni knee surgery.Case involvement, the device broke during use.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted damaged and broken two sides of the device.The cause of this condition usually is the excessive force used to pry and/or leverage the device.However, the broken pieces were not returned for investigation.The cause remains undetermined.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 3 8MM
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16751606
• Report Number: 1220246-2023-06538
• Device Sequence Number: 8528223
• Product Code: HWT
• UDI-Device Identifier: 00888867037564
• UDI-Public: 00888867037564
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 08/29/2023

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: IBAL UKA TIB BEA-RING TRL SZ 3 8MM
• Device Catalogue Number: AR-601-TBC8
• Device Lot Number: 5261843
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown