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

Catalog Number	C08-65
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation; however, provided photographic evidence exhibits the reported failure of breakage.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 was 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 a total of 19 complaints, regarding 30 devices, for this device family and failure mode.During this same time frame 11,018 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 0.003.Per the instructions for use, the user is advised the following: precautions: inspect cannula prior to use to ensure they are in good physical condition.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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that c08-65 device was being used during a rotator cuff repair procedure on (b)(6) 2019.It was reported that "arc broke at the neck point while inserting." the pictures that were sent show that the broken piece was retrieved from the patient.The event caused a 20-minute delay; however, there was no report of user or patient injury and no report of medical intervention or hospitalization.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: 8983706
• Report Number: 1320894-2019-00330
• Device Sequence Number: 18901048
• Product Code: NBH
• UDI-Device Identifier: 00653405001631
• UDI-Public: (01)00653405001631(17)230506(10)201805071
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 05/06/2023
• Device Catalogue Number: C08-65
• Device Lot Number: 201805071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR