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	06/24/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a shoulder arthroscopic procedure, the inner and outer blade sheath was not properly cutting and caused a small metallic piece to be shaved off.The case was competed by using a new ar-8500td.Additional information provided 6/30/21: the shaver attachments were opened and all of them had the same issue.The entire box was compromised and could not be used.The surgeon only used 1 during the case and opened the rest of the box to check the devices and determined this issue.The case was completed by using a new ar-8500td from a different lot.
Additional Manufacturer Narrative
Complaint confirmed.Three unpackaged ar-8500td devices were received for investigation.Visual inspection identified that each of the three returned ar-8500td had corresponding, horizontal grooves worn into the outer diameter of the cutting tip and the inner diameter of the outer tube window, consistent with sites of metal debris production.Similarly, damage was noted to the shrink tubing at the proximal end of the inner tubes, indicative of prying/leveraging.Based on the evidence observed, this event is most likely the result of prying/leveraging forces applied to the devices during use, such as against bone and/or hard tissue.

• 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
• MDR Report Key: 12198192
• Report Number: 1220246-2021-03410
• Device Sequence Number: 20144834
• Product Code: GFA
• UDI-Device Identifier: 00888867043923
• UDI-Public: 00888867043923
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 12/31/2025
• Device Model Number: TORPEDO, 5.0MM X 13 CM
• Device Catalogue Number: AR-8500TD
• Device Lot Number: 12612482
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1