MAUDE Adverse Event Report: ARTHREX, INC. CRVD ATRAUMATIC CAPSULECUT BLADE W/ HNDL; MANUAL INSTR, GENERAL SURGICAL

Model Number	CRVD ATRAUMATIC CAPSULECUT BLADE W/ HNDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a sales representative reported via (b)(4) that an ar-6527-06c safecut¿ capsulotomy blade w/ handle blade broke inside the joint.The surgeon applied very little torque to the blade, and it snapped right at the beginning of the blade's curve.The broken piece was retrieved from the patient.The case was completed successfully.This was discovered during a hip labral repair procedure on (b)(6) 2024, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure can be attributed to user error due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during use.The complaint allegation was confirmed based on the customer's attached pictures, which showed a device with the tip broken off.

• Brand Name: CRVD ATRAUMATIC CAPSULECUT BLADE W/ HNDL
• Common Device Name: MANUAL INSTR, GENERAL 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: 21218243
• Report Number: 1220246-2025-00057
• Device Sequence Number: 3568772
• Product Code: LXH
• UDI-Device Identifier: 00888867445697
• UDI-Public: (01)00888867445697(11)241011(17)290930(10)15330482
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/04/2025

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: CRVD ATRAUMATIC CAPSULECUT BLADE W/ HNDL
• Device Catalogue Number: AR-6527-06C
• Device Lot Number: 15330482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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