MAUDE Adverse Event Report: ARTHREX, INC. TORPEDO, 4.0MM X 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	TORPEDO, 4.0MM X 7CM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2021
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
On (b)(6) 2021, it was reported by a sales representative via email that an ar-7400td torpedo broke off while shaving the meniscus in the knee of the patient.All broken metal pieces were retrieved from inside the patient.This was discovered during an acl/pcl reconstruction on (b)(6) 2021.During the same procedure, while preparing a graft on the back table, an ar-1588rt-ib tightrope sutures started to shred and break off when the rnfa was pulling on a fiberwire strand.Surgeon was able to open a new torpedo and tightrope to complete procedure without further issues.
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
On (b)(6) 2021, it was reported by a sales representative via email that an ar-7400td torpedo broke off while shaving the meniscus in the knee of the patient.All broken metal pieces were retrieved from inside the patient.This was discovered during an acl/pcl reconstruction on (b)(6) 2021.During the same procedure, while preparing a graft on the back table, an ar-1588rt-ib tightrope sutures started to shred and break off when the rnfa was pulling on a fiberwire strand.Surgeon was able to open a new torpedo and tightrope to complete procedure without further issues.

• Brand Name: TORPEDO, 4.0MM X 7CM
• 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: 13152366
• Report Number: 1220246-2022-04217
• Device Sequence Number: 3696193
• Product Code: GFA
• UDI-Device Identifier: 00888867042025
• UDI-Public: 00888867042025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/04/2022

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, 4.0MM X 7CM
• Device Catalogue Number: AR-7400TD
• Device Lot Number: 14152912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown