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

Model Number	SCORPION NEEDLE, CAPSULECLOSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2025
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 (b)(6) 2025, a sales representative reported via phone that an ar-3636h suture anchor, and (2) ar-16992n scorpion¿ needles failed.This occurred during a hip labral repair on (b)(6) 2025 when the ar-3636h repair stitch did not pass through the anchor.The device was removed and another ar-3636h was used.The (2) ar-16992n broke during the first pass.All fragments were retrieved.The case continued using an ar-4068hl.There was about a 10-minute delay where additional anesthesia was administered.The representative was unsure but said he could guess the bone quality was hard.
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.Dfu-0392-sub-eo: avoid striking bone or using excessive force to pass the needle through fibrous/calcific tissue.If excessive force is encountered, replace the needle, reposition the device and pass in a different area.The complaint allegation could not be confirmed as the device was not received for investigation.

• Brand Name: SCORPION NEEDLE, CAPSULECLOSE
• 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: 22852048
• Report Number: 1220246-2025-03557
• Device Sequence Number: 4488532
• Product Code: LXH
• UDI-Device Identifier: 00888867219557
• UDI-Public: (01)00888867219557(11)241111(17)291031(10)15345156
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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, CAPSULECLOSE
• Device Catalogue Number: AR-16992N
• Device Lot Number: 15345156
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown