MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY STERLING GATOR; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	C9960A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
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.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the c9960a, sterling gator shaver blade, 2.0 mm was being used on (b)(6) 2025 and ¿we had a gator shaver (ref: c9960a/lot: 1436294) break inside a patient, loose pieces were retrieved and i am sending them in along with the rest of the part.¿ the surgeon clipped the shaver with the camera.There was no impact or injury to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The examination of the returned used device, item c9960a, found inner blade broken off at the tip.Broken piece from the inner blade was returned.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be the use of 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) reports, 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 the following: do not use burs for plunge cutting.Injury or damage may occur.Do not stall handpieces, damage can occur.Continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the c9960a, sterling gator shaver blade, 2.0 mm was being used on (b)(6) 2025 and ¿we had a gator shaver(ref: (b)(4)/lot: 1436294) break inside a patient.Loose pieces were retrieved and i am sending them in along with the rest of the part.¿ the surgeon clipped the shaver with the camera.There was no impact or injury to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: STERLING GATOR
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23392554
• Report Number: 3007305485-2025-00175
• Device Sequence Number: 21326818
• Product Code: GFA
• UDI-Device Identifier: 10845854012789
• UDI-Public: (01)10845854012789(17)300116(10)1436294
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C9960A
• Device Lot Number: 1436294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic