MAUDE Adverse Event Report: ARTHREX, INC. BIRDBEAK, 2.75MM, 22 DEGREE UP TIP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BIRDBEAK, 2.75MM, 22 DEGREE UP TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/10/2025, it was reported by a sales representative via (b)(4) that an ar-11890 birdbeak broke upon insertion in the bicep.This was discovered during the case 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
The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported and observed failure is user error.This includes misaligned insertion and/or prying or levering the device during insertion, which resulted in the device breaking.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: BIRDBEAK, 2.75MM, 22 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: 23707324
• Report Number: 1220246-2025-05297
• Device Sequence Number: 10650032
• Product Code: LXH
• UDI-Device Identifier: 00888867003774
• UDI-Public: (01)00888867003774(11)250624(10)15455639
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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, 22 DEGREE UP TIP
• Device Catalogue Number: AR-11890
• Device Lot Number: 15455639
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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