MAUDE Adverse Event Report: ARTHREX, INC. TORPEDO, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number TORPEDO, 4.0MM X 13CM

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2022

Event Type  malfunction  

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.

Event Description

On (b)(6) 2022, it was reported by a sales rep via email that the surgeon had 2x ar-8400td (torpedo, 4.0mm x 13cm) shaver blades broken in a patient during a knee arthroscopy.The blades had the same issue breaking at the distal tip inside the patient.Both blades were from the same batch (lot no.).This was discovered during use and a case was involved.To complete the procedure, a different shaver was used.

Manufacturer Narrative

Complaint was confirmed.Visual inspection found that both devices showed significant damage/deformation at the distal tip of the device.Pieces of the device are missing from the photographs.Cause is undetermined at this time, possible cause includes misuse by pushing the cutting surface into an anatomically tight space.Per the dfu for ar-8400td: "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".

• Brand Name: TORPEDO, 4.0MM X 13CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15698412
• MDR Text Key: 306895395
• Report Number: 1220246-2022-05688
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: 00888867043657
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TORPEDO, 4.0MM X 13CM
• Device Catalogue Number: AR-8400TD
• Device Lot Number: 14989993
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1