MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 6.5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED; ACCESSORIES, ARTHROSCOPIC

Catalog Number	C7312
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that this incident was originally reported to the fda under registration number 1017294 & report number 1017294-2019-00158.During processing of the record, it was determined the registration number used should be 3007305485.This report includes the original information submitted on mdr 1017294-2019-00158 as well as the corrected manufacturer and additional information regarding investigation and evaluation of the incident.The reported complaint of the seal detaching is confirmed.A visual examination of the returned used device, item c7312, found the cannula inner seal detached and was included in the return for evaluation.The visual examination was performed per design print.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 and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history for this device family and failure mode, revealed there has been a total of 1 complaints, regarding 1 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This incident was originally reported to the fda under registration number 1017294 & report number 1017294-2019-00158.During processing of the record, it was determined the registration number used should be 3007305485.This report includes the original information submitted as well as additional information regarding investigation and evaluation of the incident.Conmed received a report from the customer documenting issues with the 6.5mm x 73mm clear flexible cannula threaded, item # c7312, lot 994150, that occurred on (b)(6) 2019 at (b)(6) hospital in (b)(6).It was noted that "during acromioplasty surgery, seal was detached from a cannula and left inside of a patient body in the middle of inserting a shaver.As soon as the surgeon found it, he removed the left seal using a grasper forceps.Surgery was completed successfully using another c7312 with a 5-minute delay ".The information received noted the patient was a (b)(6) year old female and there was no impact or injury to her.Although requested, no additional information was made available.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence (fragmentation falling in the patient).

• Brand Name: 6.5MM X 73MM CLEAR FLEXIBLE CANNULA THREADED
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 9616772
• Report Number: 3007305485-2020-00006
• Device Sequence Number: 13999615
• Product Code: NBH
• UDI-Device Identifier: 10845854018873
• UDI-Public: (01)10845854018873(17)240120(10)994150
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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 Expiration Date: 01/20/2024
• Device Catalogue Number: C7312
• Device Lot Number: 994150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR