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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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
It was reported during a trial procedure the ring broke when it was being removed.This item had no effect on the patient or the case outcome.All was retrieved.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-601-tbd8, batch 5261721 was received for investigation.Visual inspection identified breakage across the trial body.The fragments generated during the event were not returned for analysis.The observed condition is most likely the result of damage incurred during the removal process, although an additional probable cause can be linked to wear and tear damage based on the age of the device.
Event or Problem Description

• 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
• MDR Report Key: 12198472
• Report Number: 1220246-2021-03423
• Device Sequence Number: 17200484
• Product Code: HWT
• UDI-Device Identifier: 00888867037625
• UDI-Public: 00888867037625
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/30/2021

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: 5261721
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1