MAUDE Adverse Event Report: ARTHREX, INC. TORPEDO, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number TORPEDO, 4.0MM X 13CM

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded by the facility.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported during an mcl reconstruction procedure, the ar-8400td torpedo broke while shaving the condyle.The sales rep reported all pieces were retrieved out of the joint.See attached image of complaint device.Additional information received on 5/21/2020: the rep reported the broken fragment was fully retrieved by using a grasper, and an unplanned incision was necessary.

• Brand Name: TORPEDO, 4.0MM X 13CM
• Type of Device: 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: 10132944
• MDR Text Key: 194476779
• Report Number: 1220246-2020-01881
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043657
• UDI-Public: 00888867043657
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TORPEDO, 4.0MM X 13CM
• Device Catalogue Number: AR-8400TD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other