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	Foreign Body In Patient (2687)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/16/2025, an fda medwatch notification was received via email.A facility representative reported that during arthroscopic shoulder surgery on (b)(6) 2025, an ar-13995n multifire scorpion needle broke, causing metal fragments to remain in the patient.
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.The device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional field information, arthrex concluded that the allegation of a broken needle was caused by user error.Dfu-0392-sub-eo, "to help avoid needle breakage and potential patient injury: do not resterilize or reuse the scorpion¿ suture passer needle.Avoid striking bone or using excessive force to pass the needle through fibrous/calcific tissue.If excessive force is encountered, replace the needle, reposition the device, and pass in a different area.Ensure a secure grasp of tissue to prevent the needle from buckling under the tissue.Avoid ¿dry,¿ repetitive actuations outside the surgical site.Abrasion of the needle surface can occur that may inhibit proper function." the complaint allegation was not confirmed.The failed device is not shown in the customer's attached picture.

• 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: 23357035
• Report Number: 1220246-2025-04751
• Device Sequence Number: 18358816
• Product Code: MDM
• UDI-Device Identifier: 00888867015951
• UDI-Public: (01)00888867015951(11)230517(17)280430(10)15094095
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: SCORPION-MULTIFIRE NEEDLE
• Device Catalogue Number: AR-13995N
• Device Lot Number: 15094095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown