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

Model Number	BUR,OVAL,FLUSHCUT,8 FLUT,5.5MMX 13CM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the anterior cruciate ligament surgery that the device broke out of its mount.The broken pieces were retrieved from the patient.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.Visual evaluation revealed that the inner hub was broken off.Functional testing was not performed due to the damage to the device.Per dfu-0215-eo - i.Device insertion and removal - for use with hand-controlled and non-hand-controlled handpieces: 1.To insert a disposable device, insert the device into the handpiece so that the plastic tab mates with the handpiece slot.The tab should be pushed in proximally as far as possible for a positive lock.The most likely cause of the reported failure can be attributed to user error of the device due to improper connection with the handpiece and/or excessive force used during use.

• Brand Name: BUR,OVAL,FLUSHCUT,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: 23294288
• Report Number: 1220246-2025-04588
• Device Sequence Number: 9926124
• Product Code: GFF
• UDI-Device Identifier: 00888867044012
• UDI-Public: (01)00888867044012(11)250210(17)300131(10)15386972
• 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): 01/29/2026

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,OVAL,FLUSHCUT,8 FLUT,5.5MMX 13CM
• Device Catalogue Number: AR-8550FOE
• Device Lot Number: 15386972
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown