MAUDE Adverse Event Report: ARTHREX, INC. CAPSULECLOSE SCORPION; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CAPSULECLOSE SCORPION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 12/04/2025, it was reported by a sales representative via (b)(4) that an ar-16992 capsuleclose scorpion tip broke off while attempting to pass suture through the capsule.This was discovered during a hip labral repair procedure with no patient harm reported.All fragments were retrieved from the patient safely and the case was completed successfully.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-16992 capsuleclose scorpion, batch 10642124, was received for investigation.Visual inspection confirmed that the tip of the tip-tube was fractured.Functional testing could not be performed due to the extent of the damage to the device tip.The most likely cause of the reported failure is user-related mechanical overstress of the device during use, including increased resistance from dense tissue or adverse device-tissue interaction during suture passage.The complaint allegation is confirmed based on the condition of the returned device.Refer to the investigation photographs.

• Brand Name: CAPSULECLOSE SCORPION
• 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: 23895416
• Report Number: 1220246-2025-05814
• Device Sequence Number: 12094649
• Product Code: LXH
• UDI-Device Identifier: 00888867212688
• UDI-Public: (01)00888867212688(11)200217(10)10642124
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: CAPSULECLOSE SCORPION
• Device Catalogue Number: AR-16992
• Device Lot Number: 10642124
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2020
• 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