MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE UKA, BASE PLATE TRIAL, SIZE 4; ORTHOPEDIC MANUAL SURG INSTR

Model Number	IBALANCE UKA, BASE PLATE TRIAL, SIZE 4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal tip on the ar-9215-1-02 glenoid drill guide handle has been compromised.After insertion of the ar-601-tbp4 poly trial with the handle, the metal connection cracked cleanly off into the trial where it is unable to be removed.The rep reported no pieces were lost, and both pieces will be returned.As the trial had already been placed, there was no further need of the base plate trial or an alternative instrument.There was no delay in surgery, a second surgery will not be needed.
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 tip of the mating part broke inside the threaded hole.The fragment could not be removed.The laser markings were also found to be discolored and faded.The most likely cause of the tip breaking is prying/leveraging.

• Brand Name: IBALANCE UKA, BASE PLATE TRIAL, SIZE 4
• 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: 19488638
• Report Number: 1220246-2024-05286
• Device Sequence Number: 18295685
• Product Code: HWT
• UDI-Device Identifier: 00888867037809
• UDI-Public: 00888867037809
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/07/2024

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: IBALANCE UKA, BASE PLATE TRIAL, SIZE 4
• Device Catalogue Number: AR-601-TBP4
• Device Lot Number: 71441606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 06/07/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown