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

Catalog Number	C9951A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the device, c9951a, sterling cuda shaver blade, 2.0 mm, was being used during a right wrist arthroscopy procedure on (b)(6) 2025 when it was reported, ¿two shavers both lot lot#1415418 broke off during a case, and a part of the tip was not recovered from the patient.The case was delayed 10 minutes.¿.There was no report of medical intervention or hospitalization for the user.The procedure was completed without an alternate device causing a 10-minute delay.The patient was reported as discharged home.This report is being raised due to the reported injury of fragmentation remaining in the patient.
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.H3 other text: device not yet received.
Additional Manufacturer Narrative
Examination of the returned used devices item c9951a, qty of 2 found inner 2.0mm cuda detached from the inner tube assembly from both returned devices.Detached inner cuda were not returned for the evaluation.Examination was performed per print a30-642-088, rev-ac.Note: customer returned a total of 3 new shaver blades, item c9951a, lot 1415418 and evaluation found no issues with returned new product.Root cause cannot be determined, however, based upon 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.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame 847,101 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 0.000006.Per the instructions for use, the user is advised do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.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 device, c9951a, sterling cuda shaver blade, 2.0 mm, was being used during a right wrist arthroscopy procedure on (b)(6) 2025 when it was reported, ¿two shavers both lot lot#1415418 broke off during a case, and a part of the tip was not recovered from the patient.The case was delayed 10 minutes.¿.There was no report of medical intervention or hospitalization for the user.The procedure was completed without an alternate device causing a 10-minute delay.The patient was reported as discharged home.This report is being raised due to the reported injury of fragmentation remaining in the patient.

• Brand Name: STERLING CUDA
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 22628726
• Report Number: 3007305485-2025-00119
• Device Sequence Number: 9074085
• Product Code: GFA
• UDI-Device Identifier: 10845854021729
• UDI-Public: (01)10845854021729(17)290918(10)1415418
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: C9951A
• Device Lot Number: 1415418
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic