MAUDE Adverse Event Report: CONMED CORPORATION FRAZIER INSTRUMENT 12FRENCH; SUCTION INSTRUMENT

Model Number	0033120
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation however the provided photographic evidence exhibits the reported failure.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been 11 complaints regarding 21 devices for this device family and failure mode.During the same time frame 19,708,449 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.000001 per the instructions for use, the user is advised the following; this suction device is indicated for use only by persons trained in suctioning procedures.This instrument is indicated for use in procedures where fine, delicate suctioning is required versus the general suctioning indicated in larger, open procedures where the yankauer or poole is used.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
It was reported via medwatch # (b)(4), that the tip of 0033120, frazier with central vent, sheared off during an anterior lumbar interbody fusion on (b)(6) 2019.The patient underwent and x-ray, the x-ray did not indicate there was any object of similar shape and size in the patient.Further assessment provided by the facility states the patient has had no issue post surgery.There was no medical treatment or additional intervention required.However, the fragment was never located.This report is being raised as patient injury due to the unknown location of the fragment and the possibility that it could remain in the patient.

• Brand Name: FRAZIER INSTRUMENT 12FRENCH
• Common Device Name: SUCTION INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 9292814
• Report Number: 1320894-2019-00386
• Device Sequence Number: 13960818
• Product Code: GCX
• UDI-Device Identifier: 30653405000147
• UDI-Public: (01)30653405000147(17)240518(10)201905201
• 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: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: 05/18/2024
• Device Model Number: 0033120
• Device Catalogue Number: 0033120
• Device Lot Number: 201905201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: 73 YR