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	03/24/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the device broke inside the patient during a knee arthroscopy although no was force applied by the surgeon and no levering was applied.No broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8400ctd (component batch 47682024) curved torpedo was received for investigation.It was identified that approximately 38.76mm of the distal end of the shaft, including the cutting tip, had broken from the assembly.Visual inspection of the breakage sites identified signs of leveraging, as damage was present to the outer diameter of the outer tube.The observed condition is most likely the result of user applied mechanical forces via prying/leveraging against bone and/or hard tissue during use.

• 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: 11648346
• Report Number: 1220246-2021-02884
• Device Sequence Number: 14411157
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 07/31/2025
• Device Model Number: 4MM CURVED TORPEDO
• Device Catalogue Number: AR-8400CTD
• Device Lot Number: 11428306
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1