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	Insufficient Information (4580)
Date of Event	06/19/2025
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 7/30/2025, an fda medwatch notification was received via email.A facility representative reported that the attachment piece of an ar-8400td torpedo shaver broke off during use.This was discovered during a procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 8/7/2025: this occurred during a right shoulder arthroscopy rotator cuff repair on (b)(6) 2025.All fragments were retrieved.The part number that completed the case is unknown.There was no case delay; however, additional anesthesia was administered.The patient's bone quality was unknown.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.-complaint allegation is not confirmed.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.Per dfu-0215-eo - 6.- f.Precautions - 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.The most likely cause for the reported failure can be attributed to user error due to allowing the rotating portion to touch any metallic object during use, that 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.

• 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: 22742260
• Report Number: 1220246-2025-03326
• Device Sequence Number: 20937320
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: (01)00888867043657(11)250326(17)300228(10)15410132
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2025

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: 15410132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 08/07/2025; 11/04/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/26/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown