MAUDE Adverse Event Report: CONMED CORPORATION GRAFTMAX BUTTON NTB (BONE, TENDON, BONE); FIXATION DEVICE

Catalog Number KS-BTB

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.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 8 complaints regarding 12 devices for this device family and failure mode.During the same time frame 30,205 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.0004 per the instructions for use, the user is advised the following; failure to measure the diameter of the graft properly may result in suture breakage due to excessive force required to advance the graft.Preoperative and operating procedures, including knowledge of surgical technique and proper selection and placement of the implant are important considerations in the successful utilization of this fixation device.It is recommended that interference screws and related insertion instrumentation be available in the event of complications during implantation.A determination for further information has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The representative reported on behalf of the facility that the ks-btb, graftmax button btb, while attempting to pass the button up and through the tunnel the suture creating the loop ripped through one bone plug hole and the second one snapped during an acl reconstruction surgery on (b)(6) 2019.The device was retrieved but retrieval was difficult and they had to dissect down to retrieve button/graft.An additional portal was created to extract the construct.No other treatment was necessary for the patient.The current status is not known of the patient.This report is being raised as an injury due to the additional portal that was needed to extract the fragment.

• Brand Name: GRAFTMAX BUTTON NTB (BONE, TENDON, BONE)
• Type of Device: FIXATION DEVICE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer Contact: melanie lannon ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 9153646
• MDR Text Key: 162458640
• Report Number: 1017294-2019-00125
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10845854402236
• UDI-Public: (01)10845854402236(17)220920(30)1(10)868142
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2022
• Device Catalogue Number: KS-BTB
• Device Lot Number: 868142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2017
• 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
• Patient Outcome(s): Other