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	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cuff repair surgery the tip of the scorpion needle broke.A piece of the needle is still in the patient supraspinatus.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.On 17-feb-2025: reveived further information that thetip of the scorpion needle broke and is still in the supra spinatus.That was seen when they took an x-ray.They decided not to do a second surgery and left the little piece 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.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.

• Brand Name: HD SCORPION NEEDLE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 21461318
• Report Number: 1220246-2025-00657
• Device Sequence Number: 7987005
• Product Code: LXH
• UDI-Device Identifier: 00888867374003
• UDI-Public: (01)00888867374003(11)240523(17)290430(10)15252973
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/08/2025

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: HD SCORPION NEEDLE
• Device Catalogue Number: AR-13999HDN
• Device Lot Number: 15252973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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