MAUDE Adverse Event Report: CONMED LARGO BULLSEYE FEMORAL GUIDE, 10MM/11MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number C8670

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2022

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the c8670, bullseye femoral guide, 10mm/11mm, was being used during a acl procedure on (b)(6) 2022 when it was reported, ¿note the c8670 femoral guide broke during the case.The tip of the guide broke off as the surgeon was hyperextending the knee while the guide was in the knee.This force caused the tip of the guide to break.It was retrieved and i have all the pieces available to return.The case was completed with no issues.This likely caused an extra 5 minutes on the case.¿ the procedure was reported as having been completed with a 5-minute delay.The fragment was removed using an arthroscopic grasper.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed without any complications.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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.This issue will continue to be monitored through the complaint system to assure patient safety.

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the c8670, bullseye femoral guide, 10mm/11mm, was being used during a acl procedure on (b)(6) 2022 when it was reported, ¿note the c8670 femoral guide broke during the case.The tip of the guide broke off as the surgeon was hyperextending the knee while the guide was in the knee.This force caused the tip of the guide to break.It was retrieved and i have all the pieces available to return.The case was completed with no issues.This likely caused an extra 5 minutes on the case.¿ the procedure was reported as having been completed with a 5-minute delay.The fragment was removed using an arthroscopic grasper.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed without any complications.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that the c8670, bullseye femoral guide, 10mm/11mm, was being used during a acl procedure on (b)(6) 2022 when it was reported, ¿note the c8670 femoral guide broke during the case.The tip of the guide broke off as the surgeon was hyperextending the knee while the guide was in the knee.This force caused the tip of the guide to break.It was retrieved and i have all the pieces available to return.The case was completed with no issues.This likely caused an extra 5 minutes on the case.¿ the procedure was reported as having been completed with a 5-minute delay.The fragment was removed using an arthroscopic grasper.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed without any complications.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Examination of the returned used device found the guide broken off at the tip and the device has damage marks on the lower shaft and handle of the device.It is suspected that excessive force was used on the device during the case and breaking guide tip off.The broken piece was not returned.The condition of the device as received is due to customer misuse.The manufacturing documents from the device history record have not been reviewed because a valid lot number was not provided.The lot history review was not conducted because a valid lot number was not provided.(b)(4).Per the instructions for use, the user is advised to inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.The ifu also advises the user to inspect instruments after use to ensure they have not been damaged.Do not use excessive force on instruments to avoid damage or breakage during use.Do not use instruments to pry, as bending or breakage may occur.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: BULLSEYE FEMORAL GUIDE, 10MM/11MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 13583624
• MDR Text Key: 286007653
• Report Number: 1017294-2022-00025
• Device Sequence Number: 1
• Product Code: NBH
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C8670
• Device Lot Number: 00027085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic