MAUDE Adverse Event Report: ARTHREX, INC. RASP, PCL; MANUAL INSTR, GENERAL SURGICAL

Model Number	RASP, PCL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 22 august 2024, it was reported by warehouse via email that an ar-1264 rasp, pcl was found in warehouse to be broken.Based off email from sales rep in attached email it appears to have occurred during use in a case on (b)(6) 2024 in (b)(6).Unknown procedure.The broken piece was recovered successfully.The case appears to have been completed successfully.There was case involvement.
Additional Manufacturer Narrative
The complain allegation was confirmed.Evaluation of the customer's photograph attached to the complaint of an alleged ar-1264 pcl rasp serial/batch number (b)(6).It was noted that the tip of the instrument was broken off at the distal end at the bend radius.The most likely cause is attributed to a user error by prying/levering the device against hard bone or other instrumentation during use.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.One unpackaged ar-1264 pcl rasp, serial/batch number (b)(6), was received for investigation.Functional testing was not performed due to the broken shaft.Visual evaluation revealed that the shaft was broken off at the distal end at the tip.Scratches and marks were observed all around the handle.The most likely reason for the reported failure is wear and tear damage incurred over repeated usage.Device manufacturing date: 05/16/2019.The complaint allegation is confirmed.

• Brand Name: RASP, PCL
• 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: 20182590
• Report Number: 1220246-2024-07499
• Device Sequence Number: 21065532
• Product Code: NBH
• UDI-Device Identifier: 00888867006744
• UDI-Public: 00888867006744
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 08/18/2025

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: RASP, PCL
• Device Catalogue Number: AR-1264
• Device Lot Number: 041527
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 08/15/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 09/30/2024; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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