MAUDE Adverse Event Report: Arthrex, Inc. HD Scorpion Needle; ORTHOPEDIC MANUAL SURG INSTR

Model Number	HD Scorpion Needle
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, an fda medsun notification was received via email.A facility representative reported that an ar-13999hdn hd scorpion needle with megaloader had the tip of the needle break off and remain in the patient during the intraoperative phase.The surgeon confirmed that a 2.5 mm metal tip was retained in the rotator cuff.The surgeon stated that attempts to identify the retained tip were unsuccessful and that further disruption of the rotator cuff to locate the tip was not pursued because it would cause harm.The surgeon explained the finding to the patient and documented the discussion.The surgeon also discussed the finding with the radiologist, and it was determined that manipulation of the rotator cuff should be discontinued and that retention of the tip would not affect the clinical outcome.This was discovered during a left shoulder arthroscopy procedure in (b)(6) 2026.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: HD Scorpion Needle
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50545524
• Report Number: 1220246-2026-04558
• Device Sequence Number: 18790750
• Product Code: LXH
• UDI-Device Identifier: 00888867374003
• UDI-Public: (01)00888867374003(11)251218(17)301130(10)15547012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/01/2026

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: HD Scorpion Needle
• Device Catalogue Number: AR-13999HDN
• Device Lot Number: 15547012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2025
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 288 LB
• Patient Race: White