MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, TIBIAL IMPACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL UKA, TIBIAL IMPACTOR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
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-611-4 batch number 051550, was received for investigation.-visual inspection identified that the head tibial impactor had a piece chipped off.No fragments were returned for analysis.Additional observation also found signs of wore, scratches, and surface irregularities on the head tibial impactor and in the shaft of the tibial impactor.A likely cause is the wear and tear damage incurred over repeated usage.
Event or Problem Description
It was reported on 08/29/2022 by a sales representative via (b)(4) that an ar-611-4 impactor is chipped, an ar-9545-t15-02 shaft is twisted, and an ar-9625 driver is twisted.This was discovered during an unspecified time with no patient harm.

• Brand Name: IBAL UKA, TIBIAL IMPACTOR
• 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: 19385683
• Report Number: 1220246-2024-03767
• Device Sequence Number: 6932972
• Product Code: LXH
• UDI-Device Identifier: 00888867223868
• UDI-Public: 00888867223868
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/23/2024

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, TIBIAL IMPACTOR
• Device Catalogue Number: AR-611-4
• Device Lot Number: 051550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 05/23/2024
• 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