MAUDE Adverse Event Report: ARTHREX, INC. BIRDBEAK, 2.75MM, 45 DEGREE UP TIP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BIRDBEAK, 2.75MM, 45 DEGREE UP TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 28-jan-2026, it was reported by a sales representative via (b)(4) that an ar-11800 birdbeak tip was broken off.This was discovered during a procedure with no patient harm.
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.One unpackaged ar-11800, birdbeak, batch 26776, was received for evaluation.Visual inspection noted that the tip was fractured.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user-related factors, such as prying and leveraging the device with excessive force.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: BIRDBEAK, 2.75MM, 45 DEGREE UP TIP
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24344609
• Report Number: 1220246-2026-00608
• Device Sequence Number: 9912563
• Product Code: LXH
• UDI-Device Identifier: 00888867003637
• UDI-Public: (01)00888867003637(10)26776
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: BIRDBEAK, 2.75MM, 45 DEGREE UP TIP
• Device Catalogue Number: AR-11800
• Device Lot Number: 26776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown