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

Model Number	IBAL UKA, TIBIAL CUT GUIDE, LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a partial knee replacement a smooth guide pin cold welded into the ar-611-trlm left tibial cutting guide.The surgeon was able to complete the cut with a single pin in place and holding the guide in place.During the procedure a small piece of the ar-601-tbe8 8mm trial broke off.The rep reported the piece was easily retrieved, but thrown out.See source data and image attached.Additional information received on 1/25/21: the trial poly broke while inserting it for trial.It broke into two distinct pieces while trialing it in the knee.The smaller piece that broke off fell onto the or table and was discarded after assessing that the two pieces accounted for the entire trial component and there was no missing piece.There were no unplanned incisions.The case was completed without difficulty, as the remaining trial component was adequate to trial and the decision for the final implantable component was made.Additional information obtained on 2/4/21: the complaint product (ar-601-tbe8 and ar-611-trlm) was returned for evaluation.The defective pin ar-613-50 (lot: 011950) was returned stuck within the guide.Upon investigation it was noted that ar-613-50 is also broken.
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, the ar-611-trlm is stuck with the ar-613-50 pin.Metal burrs were seen around the pin hole.The most likely cause for the reported failure can be attributed to wear and tear.

• Brand Name: IBAL UKA, TIBIAL CUT GUIDE, LEFT
• 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: 19495209
• Report Number: 1220246-2024-05328
• Device Sequence Number: 20968866
• Product Code: LXH
• UDI-Device Identifier: 00888867229167
• UDI-Public: 00888867229167
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBAL UKA, TIBIAL CUT GUIDE, LEFT
• Device Catalogue Number: AR-611-TRLM
• Device Lot Number: 051833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 06/09/2024
• 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