MAUDE Adverse Event Report: CONMED CORPORATION ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM; ARC CANNULA

Catalog Number C08-65

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.

Event Description

The user facility reported that during a rotary cuff procedure the c08-65 cannula broke off in the joint.The user is unsure if the broken piece was flushed out.No procedural delays or patient injury was reported.This report is being raised based on a reported malfunction with potential for injury with recurrence.

Manufacturer Narrative

(b)(4).Manufacturer narrative: the device was returned to conmed for evaluation.Visual inspection found the device was broken off at the tip.This is a technique dependent device and the most likely cause of this failure is user related.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.A two-year review of complaint history revealed one similar complaint for this product family and failure mode.In that same time frame, 8,983 units where ship and sold worldwide, making the occurrence rate of this failure 0.022 percent.A risk analysis was performed and found this failure mode and occurrence level to be acceptable and consistent with current risk documents.The instructions for use advise the user of the following.Inspect cannula prior to use to ensure they are in good physical conditions.Use carefully to ensure the cannula is not bent or collapsed when inserting the device.Avoid damaging seals and excessive leakage that they should not use devices larger than the specified cannula diameter.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM
• Type of Device: ARC CANNULA
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: martha camacho urribarri ; 525 french road; utica, NY 13502 ; 3156243051
• MDR Report Key: 7068840
• MDR Text Key: 93862045
• Report Number: 1320894-2017-00262
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2018
• Device Catalogue Number: C08-65
• Device Lot Number: 201602151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 01/08/2018
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1