MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, 10° FULL AUGMENT SIZER; MANUAL INSTR, GENERAL SURGICAL

Model Number	24MM BASEPLATE, 10° FULL AUGMENT SIZER
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/03/2021, it was reported by a facility representative via e-mail that a ar-9592-2410 baseplate is burned(melted).No additional information provided.Additional information requested.
Additional Manufacturer Narrative
The most likely cause of the reportable failure could be using the incorrect heat settings during cleaning/procedure.However, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: 24MM BASEPLATE, 10° FULL AUGMENT SIZER
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 18411682
• Report Number: 1220246-2023-09733
• Device Sequence Number: 8767727
• Product Code: LXH
• UDI-Device Identifier: 00888867343702
• UDI-Public: 00888867343702
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/28/2023

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 SIZER
• Device Catalogue Number: AR-9592-2410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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