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

Model Number	DISSECTOR, CURVED 4.0MM X 13CM
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed metal burrs and scuff markings along the od of the serrations and outer tube window of both ar-8400cds dissectors, consistent with sites of debris production.Returned, new devices of the same part/lot number combination did not display the aforementioned characteristics.This event is most likely caused by excessive bending forces applied to the device during use.
Event or Problem Description
It was reported by the sales rep that during a meniscal repair upon insertion the ar-8400cds was producing metal shaving.The surgeon changed the ar-8400cds same lot number (10212946) and the problem occurred again.The surgeon used a shaver to suction the metal shaving, the sales rep was unsure if all the metal shaving were removed.No x-ray was taking after the procedure was complete.The case was completed using a third ar-8400cds with no additional issue.

• Brand Name: DISSECTOR, CURVED 4.0MM 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: 8074735
• Report Number: 1220246-2018-00749
• Device Sequence Number: 11353710
• Product Code: GFA
• UDI-Device Identifier: 00888867043497
• UDI-Public: 00888867043497
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2018

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 Expiration Date: 04/30/2023
• Device Model Number: DISSECTOR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CDS
• Device Lot Number: 10212946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/15/2018
• 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