MAUDE Adverse Event Report: CONMED CORPORATION ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM; ACCESSORIES, ARTHROSCOPIC

Catalog Number	C08-65
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint of the wings became torn in the middle of removing forceps was confirmed.A visual examination of the returned used product, item c08-65, found the device broken off at the tip.However, critical dimensions inspected per the device print could not find any discrepancies with returned product.This is a technique dependent device and the most likely cause of this suspected failure is user related.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu advises the user to inspect cannula prior to use to ensure they are in good physical condition.Advises that to avoid damaging seals and excessive leakage, do not use with devices larger than the specified cannula diameter.Use carefully to ensure the cannula is not bent or collapsed when inserting devices.To avoid damage during use, do not use excessive force on cannula.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
On behalf of the customer, the conmed representative reported an issue with the adjustable retractor cannula 8.0mm x 65mm, item c08-65, lot # 201809171.It was reported that the device "doesn't work properly" - the outer wings of the cannula became torn in the middle of removing the forceps.Additional clarification and information received indicates that during a rotator cuff repair procedure on (b)(6) 2019 the surgeon made a small incision with a scalpel and inserted the c08-65 with arc-1000 forceps.The outer wings of the cannula were torn when removing the forceps from incision site.The wing of the cannula did tear and detach (rip-off) while still inside the patient and was removed immediately by hand by the surgeon.There were no fragments or pieces left free-floating in the patient.There was no reported impact or injury to the patient and the surgery was completed successfully using another device with a 10-minute reported delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 8418200
• Report Number: 1320894-2019-00062
• Device Sequence Number: 1516166
• Product Code: NBH
• UDI-Device Identifier: 00653405001631
• UDI-Public: (01)00653405001631(17)230916(10)201809171
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2023
• Device Catalogue Number: C08-65
• Device Lot Number: 201809171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1