MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVS RASP/TRL STEM SZ 9 LNG; MANUAL INSTR, GENERAL SURGICAL

Model Number	UNIVERS REVS RASP/TRL STEM SZ 9 LNG
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
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 device was not received for evaluation; no photos were provided.According to the event description, the most likely cause of the reported failure is wear and damage caused by repeated use and/or reprocessing.The complaint's allegation was not confirmed.
Event or Problem Description
On 05/17/2023, it was reported by a sales representative via sems that an ar-9510-12r, ar-9510-09r, and ar-9510-06r rasp is rusty and discolored.This was discovered during an unspecified time with no patient effect.

• Brand Name: UNIVERS REVS RASP/TRL STEM SZ 9 LNG
• 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: jared engle ; 8009337001
• MDR Report Key: 19505617
• Report Number: 1220246-2024-05499
• Device Sequence Number: 11757781
• Product Code: MDM
• UDI-Device Identifier: 00888867061712
• UDI-Public: 00888867061712
• 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): 06/10/2024

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: UNIVERS REVS RASP/TRL STEM SZ 9 LNG
• Device Catalogue Number: AR-9510-09R
• Device Lot Number: 250141001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2015
• 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