MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA TIB BEA-RING TRL SZ 5 9MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA TIB BEA-RING TRL SZ 5 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint is confirmed.One unpackaged ar-601-tbe9 tibial bearing trial, size 5, 9 mm serial/batch number 6791216 was received for investigation.Visual evaluation found scratches and gouges on the from and back of the device.The root cause of the reported failure mode is undetermined.However, a likely reason is the wear and tear damage incurred over repeated usage.
Event or Problem Description
On 2/2/2023, it was reported by a sales representative via email that an ar-601-tbe9 ibalance tibial bearing trial is worn.This was discovered during a procedure.Additional information received on 2/3/2023: this was discovered during a uni knee replacement procedure on (b)(6) 2023.The bearing trial was used as part of the procedure and at that time it was discovered that it was too worn.

• Brand Name: IBAL UKA TIB BEA-RING TRL SZ 5 9MM
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: jared engle ; 8009337001
• MDR Report Key: 19459328
• Report Number: 1220246-2024-04836
• Device Sequence Number: 18135963
• Product Code: HWT
• UDI-Device Identifier: 00888867037694
• UDI-Public: 00888867037694
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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 5 9MM
• Device Catalogue Number: AR-601-TBE9
• Device Lot Number: 6791216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown