MAUDE Adverse Event Report: CONMED CORPORATION 4.2MM MERLIN CUDA, EXTENDED LENGTH, 19CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number EL9356

Device Problems Bent (1059); Break (1069)

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

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned, used device found the inner cuda broken off at the poly hub and the outer cuda was found to be bent.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 a total of two complaints, regarding two devices, for this device family and failure mode.(b)(4).Per the instructions for use for the handpiece being used, the user is advised the following: precautions: prior to each use perform the following: ensure all accessories are correctly and completely attached.Perform the required preoperative functional tests for the equipment and accessories.Do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

This distributor reported that the el9356, 4.2 mm merlin cuda, extended length, 19 cm, broke at the beginning of hip arthroscopy surgery on (b)(6) 2017.The report of this incident was not received by conmed until 5apr2018.Several attempts have been made to gain more information regarding this incident; however, the distributor stated that the customer has not responded to their request.The user has stated that the patient received no injury from the incident.No delay has been reported and the surgery was completed using an alternate device.This report is being raised as a device malfunction with the potential for injury with reoccurrence.

• Brand Name: 4.2MM MERLIN CUDA, EXTENDED LENGTH, 19CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 7472008
• MDR Text Key: 107458388
• Report Number: 1017294-2018-00057
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 10845854020579
• UDI-Public: (01)10845854020579(17)190904(30)1(10)585857
• 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: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: EL9356
• Device Lot Number: 585857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1