MAUDE Adverse Event Report: ARTHREX, INC. 4MM CURVED TORPEDO; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	4MM CURVED TORPEDO
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpackaged ar-8400ctd curved torpedo (labeled with component batch 47681949) was received for investigation.Visual inspection identified that the distal end of the inner tube was not present within the returned ar-8400ctd.This would account for the lack of functionality observed during use.Additionally, breakage was noticed along the inner diameter of the outer tube window.No fragments were returned for analysis.No further issues were observed.Material analysis of the ar-8400ctd identified that the outer tube met all as-received specifications.As such, this event is most likely the result of user applied mechanical forces during use, such as through prying/leveraging against bone and/or hard tissue.
Event or Problem Description
It was reported that the device doesn`t work anymore.There was no harm or adverse event for patient, operator or third party reported.The ask surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: 4MM CURVED TORPEDO
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11692415
• Report Number: 1220246-2021-02916
• Device Sequence Number: 19875876
• Product Code: GFA
• UDI-Device Identifier: 00888867187801
• UDI-Public: 00888867187801
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/20/2021

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 Expiration Date: 02/28/2025
• Device Model Number: 4MM CURVED TORPEDO
• Device Catalogue Number: AR-8400CTD
• Device Lot Number: 10741840
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1