MAUDE Adverse Event Report: ARTHREX, INC. TORPEDO, 5.0MM X 13 CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	TORPEDO, 5.0MM X 13 CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an arthroscopic shoulder surgery a metal part of the tip of the device broke off inside the patient.The broken off part was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint is confirmed based on the customer provided photo, which displays the metal fragment being removed from the patient.However, as the complaint device will not be returned for physical evaluation, no further analysis can be conducted.The cause remains undetermined.No change in harm was identified.

• Brand Name: TORPEDO, 5.0MM X 13 CM
• Common Device Name: 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: 12393132
• Report Number: 1220246-2021-03584
• Device Sequence Number: 19928841
• Product Code: GFA
• UDI-Device Identifier: 00888867043923
• UDI-Public: 00888867043923
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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: TORPEDO, 5.0MM X 13 CM
• Device Catalogue Number: AR-8500TD
• Device Lot Number: 12785801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown