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

Model Number	LABRAL SCORPION
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-dec-2025, it was reported by a distributor via (b)(4) that an ar-13998 labral scorpion's pliers would not close completely.This was discovered during use with no further information provided.Additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information provided: it was further reported that this occurred at the end of a procedure with no patient harm or case delay.
Additional Manufacturer Narrative
Additional information: b5.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to wear-and-tear damage sustained over time in the field, consistent with the device¿s manufacturing date of 2020.

• Brand Name: LABRAL 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: 23907325
• Report Number: 1220246-2025-05869
• Device Sequence Number: 21338338
• Product Code: LXH
• UDI-Device Identifier: 00888867015999
• UDI-Public: (01)00888867015999(11)200623(10)11081634
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: LABRAL SCORPION
• Device Catalogue Number: AR-13998
• Device Lot Number: 11081634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 04/10/2026; 04/10/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/13/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2020
• 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