MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE, KNEE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCORPION NEEDLE, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
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
It was reported that during an arthroscopic suturing of the meniscus surgery when inserting the suture, the puncture needle broke.All fragments were removed from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device (fiberstitch).It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-12990n-1 knee scorpion needle was received for investigation.Visual evaluation of the returned device noted that the needle was broken at the tip.No fragments were returned for investigation.Functional testing was unable to be performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during the firing of the needle thus, breaking the needle.

• Brand Name: SCORPION NEEDLE, KNEE
• 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: 20613341
• Report Number: 1220246-2024-08415
• Device Sequence Number: 7453001
• Product Code: LXH
• UDI-Device Identifier: 00888867266520
• UDI-Public: (01)00888867266520(11)240411(17)290331(10)15233412
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N-1
• Device Lot Number: 15233412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2024
• 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