MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE, HUMPBACK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCORPION-MULTIFIRE, HUMPBACK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/14/2025, it was reported by a sales representative via (b)(4) that an ar-13995 scorpion needle broke off inside rotator cuff.This occurred during use in a case with no patient effect.The fragment was unable to be retrieved.The case was completed successfully.
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 complaint allegation is not confirmed.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle thus, breaking the needle and causing a blockage within the shaft.

• Brand Name: SCORPION-MULTIFIRE, HUMPBACK
• 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: 21766519
• Report Number: 1220246-2025-01211
• Device Sequence Number: 8582783
• Product Code: LXH
• UDI-Device Identifier: 00888867015944
• UDI-Public: 00888867015944
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/03/2025

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: SCORPION-MULTIFIRE, HUMPBACK
• Device Catalogue Number: AR-13995
• Device Lot Number: 15336345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown