MAUDE Adverse Event Report: ARTHREX, INC. HD SCORPION NEEDLE (1 PACK); ORTHOPEDIC MANUAL SURG INSTR

Model Number	HD SCORPION NEEDLE (1 PACK)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
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 a cuff repair surgery the needle stopped firing the suture through the tissue.Upon inspection the staff noticed that the needle had snapped at the tip.The needle tip could not be located.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device ( s&n first pass).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d4, h3, h6.
Additional Manufacturer Narrative
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 the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle thus, breaking the needle.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.

• Brand Name: HD SCORPION NEEDLE (1 PACK)
• 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: 20417037
• Report Number: 1220246-2024-08068
• Device Sequence Number: 15529705
• Product Code: LXH
• UDI-Device Identifier: 00888867374010
• UDI-Public: 00888867374010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/26/2025

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 (1 PACK)
• Device Catalogue Number: AR-13999HDN-1
• Device Lot Number: 15128055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: Not provided; 06/04/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/31/2024; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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