MAUDE Adverse Event Report: ARTHREX, INC. DISSECTOR, 3.5MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	AR-8350DS
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Lot number was not provided so device history record review cannot be performed.Complaint confirmed.The evaluation revealed that the returned outer tip portion broke-off from the outer shaft.Visual evaluation revealed the proximal end of the outer tip shows signs of weld penetration.The outer shaft was not returned for evaluation.The most likely cause of this event is excessive bending forces applied to the device during use.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that in (b)(6) 2016 the surgeon performed an ankle arthroscopy procedure which was a workman's compensation case.A few months after surgery an mri was performed which revealed a shaver tip had been left in the patient's ankle from the surgery.It was reported by the sales rep that the surgeon believes the tip may have broken off when the device was pulled out of the joint.On (b)(6) 2016 a second surgery was performed and the surgeon removed the piece using a grasper through a medial portal.It was reported that the patient had not been experiencing any pain from the shaver piece.

• Brand Name: DISSECTOR, 3.5MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5857615
• Report Number: 1220246-2016-00336
• Device Sequence Number: 1242510
• Product Code: GFA
• UDI-Device Identifier: 00888867043299
• UDI-Public: 00888867043299
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AR-8350DS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2016
• Initial Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR