MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 10° FULL AUGMENT TRIAL; ORTHOPAEDIC TEMPLATE

Model Number	24MM BASEPLATE, 10° FULL AUGMENT TRIAL
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
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.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.
Event or Problem Description
On 7/27/2022, it was reported by a sales representative via email that an ar-9594-2410 24 mm baseplate trial got melted from a bovi.This was discovered once the procedure was completed on (b)(6) 2022, patient was not affected.

• Brand Name: 24MM BASEPLATE, 10° FULL AUGMENT TRIAL
• Common Device Name: ORTHOPAEDIC TEMPLATE
• 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: 19179774
• Report Number: 1220246-2024-02354
• Device Sequence Number: 7280450
• Product Code: HWT
• UDI-Device Identifier: 00888867343801
• UDI-Public: 00888867343801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/25/2024

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: 24MM BASEPLATE, 10° FULL AUGMENT TRIAL
• Device Catalogue Number: AR-9594-2410
• Device Lot Number: 375902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown