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 Connection Problem (2900)

Patient Problem Discomfort (2330)

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-8400td was received for investigation.Visual inspection under magnification revealed that the inner diameter of the outer tube hood was chipped.The cause remains undetermined, although a probable cause can be attributed between interference between the device and bone or other instrumentation during use.

Event Description

On (b)(6) 2021, it was reported by an arthrex employee via sems that an ar-8400td torpedo was shaped different from its usual and there was a discomfort when it was attached to the handpiece.This was discovered during a procedure on (b)(6) 2021.A new device was used to complete case and patient was not affected.During returned device evaluation, a reportable malfunction was discovered.

• 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: 13397491
• MDR Text Key: 286938937
• Report Number: 1220246-2022-04370
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: 00888867043657
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• 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: 12206521
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1