MAUDE Adverse Event Report: CONMED LARGO 3.5 MM GREAT WHITE STEALTH; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	S9399A
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the, s9399a, 3.5 mm great white stealth device was being used on (b)(6) 2022 during a knee arthroscopy procedure and ¿one of the teeth was made incorrectly and pointed in the wrong direction, this caused the tooth to scratch on the cartilage.The cartilage was damaged on the condyle due to the defect on the shaver blade.¿ the procedure was completed with an alternate same device.There was a 10 minute delay to the procedure.After further assessment it was found ¿the device was inspected before use, but this was not seen then, because the teeth are so small.¿ there was a tear on the cartilage on the tibia in the knee that does not need to be fixed.The current status of the patient is good.There was no extended stay at the hospital for the patient and no medical/surgical intervention.This report is being raised on the basis of injury due to tear to the tibia.
Additional 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.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the, s9399a, 3.5 mm great white stealth device was being used on 24apr22 during a knee arthroscopy procedure and ¿one of the teeth was made incorrectly and pointed in the wrong direction, this caused the tooth to scratch on the cartilage.The cartilage was damaged on the condyle due to the defect on the shaver blade.¿ the procedure was completed with an alternate same device.There was a 10 minute delay to the procedure.After further assessment it was found ¿the device was inspected before use, but this was not seen then, because the teeth are so small.¿ there was a tear on the cartilage on the tibia in the knee that does not need to be fixed.The current status of the patient is good.There was no extended stay at the hospital for the patient and no medical/surgical intervention.This report is being raised on the basis of injury due to tear to the tibia.
Additional Manufacturer Narrative
Customer complaint of one of the teeth was made incorrectly and pointed in the wrong direction, this caused the tooth to scratch on the cartilage was confirmed.Visual examination of the returned device, item s9399a confirm the reported problem and found outer tube machined incorrectly.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 was 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 1 report, regarding 1 device, for this device family and failure mode.During this same time frame (b)(4) 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).Per the instructions for use, the user is advised the following: prior to each use ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 3.5 MM GREAT WHITE STEALTH
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 14355294
• Report Number: 1017294-2022-00055
• Device Sequence Number: 11798003
• Product Code: GFA
• UDI-Device Identifier: 10845854605677
• UDI-Public: (01)10845854605677(17)241003(10)1051055
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2024
• Device Model Number: S9399A
• Device Catalogue Number: S9399A
• Device Lot Number: 1051055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic