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	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/25/2025, it was reported by a sales representative via (b)(4) that an ar-6527-07 capsule blades are dull and aren't cutting tissue effectively.Noticed during a case with no patient effect.Additional information 12/5/25: malfunction occurred during a hip arthroscopy with labral repair and was able to complete case with capsule blades from a different lot number.
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-6527-07, atraumatic capsulecut blade, batch 15477984, was received for investigation.Visual inspection noted that the device was sealed in both the outer and inner pouches.Upon opening the packaging, no issues were noted with the device's exterior.No problem found.The complaint allegation is not confirmed.

• 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: 23816368
• Report Number: 1220246-2025-05624
• Device Sequence Number: 9299714
• 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): 03/24/2026

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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