MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 4 8MM; ORTHOPEDIC, MANUAL SURGICAL INSTRUMENT

Model Number	IBAL UKA TIB BEA-RING TRL SZ 4 8MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/05/2023, it was reported by a sales representative via sems that an ar-601-tbd8 tibial bearing trial broke.This occurred during a case, with no patient effect reported.No additional information was provided.Additional information is requested.
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.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided photo.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during insertion/extraction of the trial.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 4 8MM
• 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: 16846008
• Report Number: 1220246-2023-06648
• Device Sequence Number: 7547663
• Product Code: HWT
• UDI-Device Identifier: 00888867037625
• UDI-Public: 00888867037625
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/14/2024

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: IBAL UKA TIB BEA-RING TRL SZ 4 8MM
• Device Catalogue Number: AR-601-TBD8
• Device Lot Number: 5261910
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown