MAUDE Adverse Event Report: ARTHREX, INC. ATRAUMATIC CAPSULECUT BLADE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ATRAUMATIC CAPSULECUT BLADE
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 18-feb-2026, it was reported by a sales representative via (b)(4) that an ar-6527-07 capsule blade is dull and had trouble cutting through the capsule.Noticed during a case but able to be completed with no patient effect.Additional info provided 3-mar-2026: device swapped for ar-6527-02c and case completed with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: ATRAUMATIC CAPSULECUT BLADE
• 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: 24567813
• Report Number: 1220246-2026-01347
• Device Sequence Number: 8366707
• Product Code: LXH
• UDI-Device Identifier: 00888867445703
• UDI-Public: (01)00888867445703(11)250805(17)300731(10)15477984
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: ATRAUMATIC CAPSULECUT BLADE
• Device Catalogue Number: AR-6527-07
• Device Lot Number: 15477984
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown