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	06/16/2025
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 (b)(6) 2025, it was reported by an arthrex employee that an ar-16992 tip broke inside the hip.This was discovered during a hip arthroscopy procedure.After pulling out the instrument, 2 more pieces came off, one was the spring.The 1 piece that detached inside the boy was taken out.The other two pieces detached outside the body when the hospital nurse passed the instrument back to the scrub nurse.The case was completed successfully.
Additional Manufacturer Narrative
Additional information: complaint allegation is confirmed by the attached picture, which shows the tip/distal end of the shaft of the capsule close scorpion broken off.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 was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to wear and tear due to repeated use of the device in the field.Manufactured 2018.

• 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: 22493770
• Report Number: 1220246-2025-02842
• Device Sequence Number: 7940714
• Product Code: LXH
• UDI-Device Identifier: 00888867212688
• UDI-Public: (01)00888867212688(11)180814(10)10231126
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: CAPSULECLOSE SCORPION
• Device Catalogue Number: AR-16992
• Device Lot Number: 10231126
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 10/26/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male