MAUDE Adverse Event Report: ARTHREX, INC. HD SCORPION NEEDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HD SCORPION NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
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
On 11/13/2024, it was reported by a sales representative via (b)(4) that an ar-13999hdn scorpion needle tip broke when it was fired.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-13999hdn hd scorpion¿ needle was received for investigation.Visual evaluation of the returned device noted that the tip was broken and missing a fragment.It was further noted that the end of the needle was significantly bent.Functional testing was not 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 and causing a blockage within the shaft.Dfu-0392-sub-eo warns against the usages listed to help avoid needle breakage and potential patient injury.Refer to investigation photos.

• Brand Name: HD SCORPION NEEDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 20902489
• Report Number: 1220246-2024-08778
• Device Sequence Number: 14703422
• Product Code: LXH
• UDI-Device Identifier: 00888867374003
• UDI-Public: (01)00888867374003(11)240507(17)290430(10)15245105
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 15245105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown