MAUDE Adverse Event Report: ARTHREX, INC. IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 6; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
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 confirmed.One unpackaged ar-623-56 was received for investigation.Visual inspection identified breakage across the dovetail feature consistent with the allegation.Due to the returned condition of the device, the dimensions of the feature could not be accurately assessed.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.
Event or Problem Description
On 11/29/2021, it was reported by a sales representative via e-mail that an ar-623-56 tka broke and become stuck.This was discovered on (b)(6) 2021 during a tka when the surgeon was using the slap hammer to remove the 4 in 1 cutting block and the connector on the block snapped off inside the slap hammer and could not be removed.The case was completed by using another ar-623-56.

• Brand Name: IBAL POROUS TKA,CUT BLK,4 IN 1,SZ 6
• 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: 19478067
• Report Number: 1220246-2024-05090
• Device Sequence Number: 4036319
• Product Code: LXH
• UDI-Device Identifier: 00888867214736
• UDI-Public: 00888867214736
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 06/06/2024

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 POROUS TKA,CUT BLK,4 IN 1,SZ 6
• Device Catalogue Number: AR-623-56
• Device Lot Number: 221536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown