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	Foreign Body In Patient (2687)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 10-dec-2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8400td torpedo, when activated inside the joint, made a strange noise.It was removed from the joint, inspected, and noted that the tip of the blade was broken, which remains inside the blade.This was discovered during an acl procedure with no patient harm.The case was completed successfully with another device.Additional information provided on 16-dec-2025: it was further reported that at the end of the surgery, an x-ray was taken to check the position of the cruciate button, and it was noted that one of the blade fragments remained inside the joint.It was also indicated that there was a 20¿30-minute delay as they had to go back into the joint to try to remove the fragment, although it could not be removed.No additional anesthesia was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Correction: updated h1 from malfunction to serious injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the documented event information, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, the most likely causes of the device break were one or more of the following contributing factors: 1.Excessive side-loading, which can lead to damage, as stated in dfu-0215-eo.2.The rotating portion of the device makes contact with other instruments, such as a cannula or arthroscope, during use.3.Forcing the hood of any burrs into anatomically tight spaces can cause the burr tip to collide.Directions for use - dfu-0215-eo revision 1 - disposable arthroscopic shaver blades, burrs, powerpick¿, powerasp¿, nanoresection¿ and shaverdrill¿ devices 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 allegation was confirmed based on the evaluation of the customer-provided image, which showed the inner shaft tip blades broken off.Additional damage, including nicks, was also observed on the cutting blades of the external shaft.

• 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: 23936015
• Report Number: 1220246-2025-05943
• Device Sequence Number: 9611303
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: (01)00888867043657(11)250508(17)300430(10)15433542
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/15/2026

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: 15433542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided; 04/14/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/10/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2025
• 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