MAUDE Adverse Event Report: ARTHREX, INC. COMBINED RASP+ELEVATOR MEDIUM; MANUAL INSTR, GENERAL SURGICAL

Model Number	COMBINED RASP+ELEVATOR MEDIUM
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/19/2025, a facility representative reported via (b)(4) that an ar-8880-01 rasp and blunt elevator small, ar-8880-02 rasp and blunt elevator medium, ar-8880-03 combi-elevator straight and curved ends, and an ar-8954-05 elevator sayre 9mm x6.5'' handles are thin and require a tight grip that fatigues the hand.The sharp edge is too sharp, and in some bone it goes into the bone - which is not the ideal aspect.It should be more like a freer tip vs a sharp edge.This occurred during a case.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse due to improper surgical technique.

• Brand Name: COMBINED RASP+ELEVATOR MEDIUM
• 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: 21535506
• Report Number: 1220246-2025-00790
• Device Sequence Number: 17917017
• Product Code: LXH
• UDI-Device Identifier: 00888867129917
• UDI-Public: 00888867129917
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: COMBINED RASP+ELEVATOR MEDIUM
• Device Catalogue Number: AR-8880-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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