MAUDE Adverse Event Report: ARTHREX, INC. UNI REVERS HUMERAL RESECTION SLIDE BLOCK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNI REVERS HUMERAL RESECTION SLIDE BLOCK
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the uni revers humeral resection slide block has a rusty screw.It was noticed after the surgery.There was no harm for patient, operator or third party.There was no case involvement reported.No further information received.
Additional Manufacturer Narrative
Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.A most likely cause for the reported type of event is attributed to the usage of low acid or alkaline solutions for the cleaning.

• Brand Name: UNI REVERS HUMERAL RESECTION SLIDE BLOCK
• 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: 18942451
• Report Number: 1220246-2024-01562
• Device Sequence Number: 16852265
• Product Code: LXH
• UDI-Device Identifier: 00888867266001
• UDI-Public: 00888867266001
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: UNI REVERS HUMERAL RESECTION SLIDE BLOCK
• Device Catalogue Number: AR-9507RGDP-1
• Device Lot Number: 051818
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2018
• 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