MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 5 9MM; TEMPLATE FOR CLINICAL USE

Model Number	IBAL UKA TIB BEA-RING TRL SZ 5 9MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
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 e-mail that an ar-601-tbe9 tibial insert trial broke upon removal from the knee.This was discovered during an uka procedure on (b)(6) 2021.The broken fragment was retrieved and the case was completed.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-601-tbe9 was received for investigation.Visual inspection identified that the trial body had broken along the outer diameter, with surface damage present across the remaining material.The thickness of the returned ar-601-tbe9 was assessed using digital micrometer id: 224, and was identified to meet design specifications.A probable cause is attributed to damage incurred during the removal process.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 5 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: 13154403
• Report Number: 1220246-2022-04237
• Device Sequence Number: 14764418
• Product Code: HWT
• UDI-Device Identifier: 00888867037694
• UDI-Public: 00888867037694
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 01/21/2022

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 5 9MM
• Device Catalogue Number: AR-601-TBE9
• Device Lot Number: 5261640
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown