MAUDE Adverse Event Report: CONMED CORPORATION ALLIGATOR GRASPER, STRAIGHT, 3.4MM X 130MM; FORCEPS, DISSECTING

Catalog Number 11.1002

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

To date, the reported device has not been received at conmed for evaluation.Should the device be returned, an evaluation will be performed.Upon completion of the complaint investigation a supplemental and final report will be filed.

Event Description

The conmed sales representative reported on behalf of their customer that the alligator grasper, straight, 3.4mm x 130mm item # 11.1002, serial # (b)(4) device broke during a knee arthroscopic procedure to remove a loose body on (b)(6) 2018.The surgeon performed the arthroscopy and located the bony loose body fragment to remove from knee joint.After approximately 30-40minutes into the procedure, the surgeon introduced the grasper and grabbed the fragment.When he tried to remove the loose body, there was an audible snap and the lower half of the jaw on the grasper was gone.He spent an hour searching the joint with an arthroscopic camera and assistance of fluoroscopy.The alligator grasper lower jaw fragment was located but in a very difficult area to reach in posterior medial portion of knee.The grasper fragment kept drifting deeper and deeper until it was no longer in view and lodged in soft tissues on the posterior medial portion of knee.The surgeon, then fearing more damage to the knee from searching, decided to stop the procedure.The surgery was delayed by the 1 hour mentioned.This report is being raised on the basis of patient injury.

Manufacturer Narrative

It was previously reported that a review of the device history records was not completed since the device had been in the field for more than 12 months.The manufacturing documents from the device history record have been located and reviewed.Special attention was paid 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Manufacturer Narrative

To date, although expected, the device in question has not been received into the conmed complaint system.The photographic evidence provided confirmed the reported complaint.The device has been in the field for more than 12 months therefore the manufacturing documents from the device history record have not been reviewed.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.During this same time frame 9,996 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).The instructions for use (ifu) provides the user with information regarding the proper care and use of this device.It is standard medical practice to inspect and/or test all medical equipment prior to use.The ifu also advises the user of the following: inspect the instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the user of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Instrument is designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques for use.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: ALLIGATOR GRASPER, STRAIGHT, 3.4MM X 130MM
• Type of Device: FORCEPS, DISSECTING
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 8124529
• MDR Text Key: 129045345
• Report Number: 1017294-2018-00177
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 11.1002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/12/2018; 01/04/2019
• Supplement Dates FDA Received: 12/19/2018; 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other