MAUDE Adverse Event Report: CONMED LARGO STERLING GATOR; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	C9960A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, c9960a, sterling gator shaver blade, 2.0 mm, was being used during a wrist scope procedure on (b)(6)2025 when it was reported, ¿shaver blade broke off in the joint during arthroscopic shaving.¿.The procedure was reported as having been completed.Further assessment questioning was sent to the reporter; however, no response has been received to date.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported injury of blade broken in wrist and with possible fragmentation retained in body.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided.Root cause cannot be determined, however, based upon photos and the ifu; a possible cause of this event could be excessive force.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 (b)(4) complaints, regarding (b)(4) devices, 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 to always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.Direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices.If contact does occur, shaver blades can break, seize, or shed metal particles.Shaver blade or bur should be examined for damage and replaced if necessary.Do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the device, c9960a, sterling gator shaver blade, 2.0 mm, was being used during a wrist scope procedure on (b)(6)2025 when it was reported, ¿shaver blade broke off in the joint during arthroscopic shaving.¿.The procedure was reported as having been completed.Further assessment questioning was sent to the reporter; however, no response has been received to date.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported injury of blade broken in wrist and with possible fragmentation retained in body.

• Brand Name: STERLING GATOR
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 21206668
• Report Number: 1017294-2025-00007
• Device Sequence Number: 8071635
• Product Code: GFA
• UDI-Device Identifier: 10845854012789
• UDI-Public: (01)10845854012789(17)280827(10)1337024
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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 Catalogue Number: C9960A
• Device Lot Number: 1337024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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