MAUDE Adverse Event Report: ARTHREX, INC. 4MM CURVED TORPEDO; SAW BLADE

Model Number	4MM CURVED TORPEDO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/01/2024, it was reported by a sales representative via (b)(4).That an ar-8400ctd 4mm curved torpedo shaver was broken.The shaft of the shaver attachment was bent and pieces of metal were sticking out of the shaft.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8400ctd serial/batch number (b)(6) was received for investigation.Visual evaluation under a magnifier noted damage and striation marks along the shaft of the outer tube.Functional testing was not performed due to the damage of the device.Dfu-0215-7; precautions 1-15; states the following: "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.8.Excessive ¿loading¿ on the powerasp device will disengage the cam mechanism and stall the cutting effectiveness.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.All arthrex disposable arthroscopic devices are preassembled, packaged sterile, and ready for use.Irreversible damage will result from any attempt to disassemble curved blades, flushcut burrs, clearcut burrs, powerpick, shaver flipcutter® and powerasp devices.12.If disassembly of straight devices is required to remove a clog, care must be taken to prevent damage to the teflon tubing on the inner tube during re-assembly.13.A thrust washer on straight burrs can be dislodged if disassembly is required to remove a clog, the thrust washer must be snapped onto the inner hub prior to re-assembly in order to prevent damage during use.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.15.Powerpick device tips can bind in bone and render the device inoperable if the device is stopped while inserted in bone and/or if the angle of the rotating tip is changed while drilling.Make sure handpiece is off while changing device tip position.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: 4MM CURVED TORPEDO
• 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: 19175852
• Report Number: 1220246-2024-02341
• Device Sequence Number: 19779480
• Product Code: GFA
• UDI-Device Identifier: 00888867187801
• UDI-Public: 00888867187801
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2024

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: 4MM CURVED TORPEDO
• Device Catalogue Number: AR-8400CTD
• Device Lot Number: 15142594
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• 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