MAUDE Adverse Event Report: ARTHREX, INC. TORPEDO, 4.0MM X 13CM; SAW BLADE

Model Number	TORPEDO, 4.0MM X 13CM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
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 descriptions, and any additional information from the field, arthrex concluded that the most likely cause(s) for the reported failure can be a user error caused by misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.Directions for use (dfu) dfu-0215-eo disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection and shaverdrill¿ devices.E.Warnings.5.Failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure.F.Precautions.6.Do not allow the rotating portion of any device to touch any metallic object, such as a cannula or arthroscope, during use.Damage to both devices is likely.Damage to the device can range from a slight distortion or dulling of the blade/burr edge to actual fracture of the tip in vivo.If such contact does occur, inspect the tip.If there are cracks, fractures or dulling, or if there is any other reason to suspect a blade is damaged, replace it immediately.7.Excessive "side-loading" on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.14.Forcing the hood of any burrs, including flushcut burrs and clearcut burrs into anatomically tight spaces can cause the burr tip to collide with the hood and render the device inoperable.The complaint is confirmed based on the customer¿s attached picture, which displays the inner shaft cutting tip blades broken off.Additionally, damage was noted on the cutting edges of the outer shaft¿s tip.
Event or Problem Description
On 17th january 2025, it was reported by an arthrex employee via email that an ar-8400td, torpedo, 4.0 mm x 13 cm shaver blade had a broken tip.This was detected during a bankart repair and repassage procedure on (b)(6) 2025.The torpedo shaver was used in normal fashion to debride remnant suture.Shaver fragment was visually displaced on arthroscopic view.On removal, the tip was found to be broken.All fragments were contained within the tip.Procedure was successfully completed with no patient harm by using ar-8400ex.Intra-op x-ray showed no fragments remained in patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: TORPEDO, 4.0MM X 13CM
• Common Device Name: SAW BLADE
• 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: 21323532
• Report Number: 1220246-2025-00279
• Device Sequence Number: 21006626
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: (01)00888867043657(11)240708(17)290630(10)15283769
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/10/2025

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: TORPEDO, 4.0MM X 13CM
• Device Catalogue Number: AR-8400TD
• Device Lot Number: 15283769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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