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	02/05/2025
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 18 february 2025, it was reported by a sales representative via email that an ar-8400td torpedo, 4.0mm x 13cm was reported to have the tip missing immediately after use.This occurred on (b)(6) 2025 in royston day surgery during a knee arthroscopy.It was reported the torpedo was in use during a routine procedure and it was noticed the tip of the inner blade was missing and potentially retained within the patient or suctioned away.Just prior to noticing the missing tip, the torpedo was making an unusual noise.The staff cannot say for certain whether the tip was present at the start of the procedure before use, or not.No x-ray was taken.No further details are available at this time.No lot or batch number is available and the item has not been kept or photographed.The case was completed successfully using the same device.There was case involvement.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error.Forcing the hood of any burrs, including flush-cut and clear-cut burrs, into anatomically tight spaces can cause the burr tip to collide with the hood, rendering the device inoperable.The complaint allegation was not confirmed.No evidence of the failure was received.

• 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: 21444542
• Report Number: 1220246-2025-00602
• Device Sequence Number: 7290095
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: 00888867043657
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 07/14/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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