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

Model Number	SUREFIRE SCORPION NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/21/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-13991n surefire¿ scorpion¿ needle broke.This occurred during a case.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was provided on (b)(6) 2025 where it was stated this event occurred during a shoulder arthroscopy when the doctor went to activate the forceps the device broke.A scorpions forceps was used with the needle.The patient had a normal bone quality that was prepped using a shaver blade.Another needle was opened to proceed with the case.A fragment remains in the patient.There was no delay in the procedure.
Event or Problem Description
Additional information was provided on 08/14/2025 where it was stated this event occurred during a shoulder arthroscopy when the doctor went to activate the forceps the device broke.A scorpions forceps was used with the needle.The patient had a normal bone quality that was prepped using a shaver blade.Another needle was opened to proceed with the case.A fragment remains in the patient.There was no delay in the procedure.
Additional Manufacturer Narrative
Additional info: b5, g3, h3, h6.The complaint 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 information from the field, arthrex was able to conclude the most likely cause.The reported failure is caused by a user error, specifically applying excessive force to pass the needle through fibrous/calcific tissue and/or ¿dry,¿ repetitive actuations outside the surgical site, as stated in the directions for use (dfu-0392-sub-eo warning for scorpion products).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 could not be confirmed.The device was not received for evaluation, and no supporting evidence of the reported failure was provided.

• Brand Name: SUREFIRE SCORPION 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: 22748801
• Report Number: 1220246-2025-03345
• Device Sequence Number: 15871197
• Product Code: MDM
• UDI-Device Identifier: 00888867015920
• UDI-Public: (01)00888867015920(11)241014(17)290930(10)15331441
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 08/28/2025

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: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N
• Device Lot Number: 15331441
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 08/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/27/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown