MAUDE Adverse Event Report: ARTHREX, INC. BUR,RND,CLEARCUT,8 FLUT,5.5MMX 13CM; BURR,SURGICAL

Model Number	BUR,RND,CLEARCUT,8 FLUT,5.5MMX 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic hip surgery the device broke.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-8550cre was received for investigation.The device was unable to be fully decontaminated and was evaluated via pictures.Visual evaluation of the attachments noted a small unidentifiable white fragment near the burr of the device.This found failure can be assumed to be related to the reported failure.Functional testing was not performed due to the biocontamination hazard risk.The most likely cause for the reported failure can be attributed to use error due to prying/leveraging the device during use and/or allowing it to come into contact with another object.

• Brand Name: BUR,RND,CLEARCUT,8 FLUT,5.5MMX 13CM
• Common Device Name: BURR,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: 22558254
• Report Number: 1220246-2025-02996
• Device Sequence Number: 18566830
• Product Code: GFF
• UDI-Device Identifier: 00888867043978
• UDI-Public: (01)00888867043978(11)230703(17)280630(10)15111223
• 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): 10/07/2025

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: BUR,RND,CLEARCUT,8 FLUT,5.5MMX 13CM
• Device Catalogue Number: AR-8550CRE
• Device Lot Number: 15111223
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown