MAUDE Adverse Event Report: CONMED LARGO GRAFIX TUNNEL NOTCHER, 1.5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number C8106

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/19/2022

Event Type  Injury  

Event Description

The sales representative reported on behalf of the customer that the device, c8106, grafix tunnel notcher, 1.5mm was being used on (b)(6) 2022 during an anterior cruciate ligament procedure and the ¿tip broke off in patient during surgery.Was not noticed until after procedure.As of now, no patient harm.Tip is sitting in-between bone block and screw.Dr.Is leaving in unless fear of movement is detected¿.After further assessment it was found there was no report of medical/surgical intervention or prolonged hospitalization.The procedure was completed as normal and there was no delay.The device was inspected before use.The tip is being left in the patient for now and the dr.Is not planning a 2nd surgery to remove the fragment.The patient is "recovering as normal".This report is being raised on the basis of injury due to fragment remaining in the patient.

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 device has not been returned for evaluation to date and no photographic evidence was provided; therefore, the event cannot be verified.A device history record could not be reviewed as a valid lot number was not reported.A lot history could not be reviewed as a valid lot number was not reported.A two-year review of complaint history revealed there has been a total of 1 reports, regarding 1 devices, for this device family and failure mode.During this same time frame 2,157 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 0.0005.Per the instructions for use, the user is advised the following: inspect instruments prior to use for proper function; no loose pins or misalignment and that the instrument is in good physical condition.Inspect instruments after use to ensure it has not been damaged.Do not use excessive force on instruments to avoid damage or breakage during use.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 device, c8106, grafix tunnel notcher, 1.5mm was being used on (b)(6) 2022 during an anterior cruciate ligament procedure and the ¿tip broke off in patient during surgery.Was not noticed until after procedure.As of now, no patient harm.Tip is sitting in-between bone block and screw.Dr.Is leaving in unless fear of movement is detected¿.After further assessment it was found there was no report of medical/surgical intervention or prolonged hospitalization.The procedure was completed as normal and there was no delay.The device was inspected before use.The tip is being left in the patient for now and the dr.Is not planning a 2nd surgery to remove the fragment.The patient is "recovering as normal".This report is being raised on the basis of injury due to fragment remaining in the patient.

• Brand Name: GRAFIX TUNNEL NOTCHER, 1.5MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 15157907
• MDR Text Key: 297165664
• Report Number: 1017294-2022-00086
• Device Sequence Number: 1
• Product Code: LXH
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C8106
• Device Lot Number: 21976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic