MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 3 9MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL UKA TIB BEA-RING TRL SZ 3 9MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
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) 2022, it was reported by a sales representative via sems that an ar-601-tbc9 ibalance¿ uka, tibial bearing trial, size 3, 9 mm broke during a case.This was discovered during use with no impact to the patient.On (b)(6) 2022, the sales representative stated the following information via email: this event occurred during a primary uni knee procedure on (b)(6) 2022.The instrument was not used with power.The device broke as they were trying to get it out of the patient.It was removed in two pieces, it got stuck and when removing it, the piece popped off and went flying to the floor.They were done trialing when the device broke, so there was no impact to the patient.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 3 9MM
• 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: 13929217
• Report Number: 1220246-2022-04670
• Device Sequence Number: 4843480
• Product Code: HWT
• UDI-Device Identifier: 00888867037571
• UDI-Public: 00888867037571
• 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
• Report Date (Section B): 03/28/2022

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 3 9MM
• Device Catalogue Number: AR-601-TBC9
• Device Lot Number: 5261719
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/28/2022
• Date Device Manufactured: 05/18/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown