MAUDE Adverse Event Report: ARTHREX, INC. SCORPION-MULTIFIRE NEEDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	SCORPION-MULTIFIRE NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
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 10/06/2025, a facility representative reported via (b)(4) that an ar-13995n scorpion multifire needle broke on the pass through during a during a case with no harm to the patient.Additional information received on 10/10/25 advised that the needle broke while passing a suture through rcr during a shoulder scope without harming the patient.No attachment was used with the needle.All pieces were retrieved from the patient, which caused a two-minute delay, and the scope was completed using an hd scorpion needle.No additional anesthesia was administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 user error of the device due to excessive force being used during firing of the needle.

• Brand Name: SCORPION-MULTIFIRE NEEDLE
• 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: 23349693
• Report Number: 1220246-2025-04718
• Device Sequence Number: 12751793
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: (01)00888867015951(11)220712(17)270630(10)14980542
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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 NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 14980542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown