MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 4 8MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL UKA TIB BEA-RING TRL SZ 4 8MM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2021
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
On (b)(6) 2021 it was reported by a sales representative via sems that an ar-601-tbd8 tibial bearing trial was broken during insertion.This occurred during a total shoulder procedure.All was retrieved.No harm to the patient.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-601-tbd8 was received for investigation.Visual inspection identified breakage across one corner of the trial, likely a result of damage incurred during the removal process.No other abnormality was noted.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 4 8MM
• Common Device Name: TEMPLATE FOR CLINICAL USE
• 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: 12616725
• Report Number: 1220246-2021-03789
• Device Sequence Number: 3973280
• Product Code: HWT
• UDI-Device Identifier: 00888867037625
• UDI-Public: 00888867037625
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/10/2022

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: IBAL UKA TIB BEA-RING TRL SZ 4 8MM
• Device Catalogue Number: AR-601-TBD8
• Device Lot Number: 5261932
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown