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 Code	Foreign Body In Patient (2687)
Date of Event	11/26/2025
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 11/27/2025, an arthrex subsidiary employee reported via (b)(4) that an ar-13991n surefire scorpion needle tip broke during a suture passage, and another suture passer was used.The needle tip remained inside the joint, causing a 30-minute delay in the rotator cuff repair procedure.Additional information was received on 12/05/25.The rep advised that it was reported that the surgeon was attempting to pass the needle through the cuff to place the stitch, with no other device involved at the time.They attempted to remove the fragment of the broken needle but were unsuccessful.The exact additional time could not be quantified; however, it was reported that the surgeon spent some time trying to remove the fragment and eventually gave up.
Additional Manufacturer Narrative
Additional information: 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 most likely cause of the reported failure is user error, such as striking bone or applying excessive force when attempting to pass the needle through fibrous or calcified tissue, as warned in the directions for use.(dfu-0392-sub).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, as the device was not received for evaluation, and no 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: 23830109
• Report Number: 1220246-2025-05669
• Device Sequence Number: 14710376
• Product Code: MDM
• UDI-Device Identifier: 00888867015920
• UDI-Public: (01)00888867015920(11)250416(17)300331(10)15421382
• 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
• Report Date (Section B): 04/02/2026

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: SUREFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13991N
• Device Lot Number: 15421382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown