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

Catalog Number	C9911
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
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 customer reported that the device, c9911, sterling spherical bur, microblade, 2.9 mm, was used during an arthroscopic carpal tunnel syndrome (cm) joint formation procedure on (b)(6) 2026 when it was reported, ¿immediately after starting to use the abrader bur under endoscopic guidance, the ball-shaped tip of the bur broke off and detached.We have received a report that the detached part was removed, so there are no remaining remnants in the body, and there is no impact on the patient.¿ there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned with no reported delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: STERLING
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED; 525 french rd.; utica NY 13502
• 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: 24712356
• Report Number: 1017294-2026-00035
• Device Sequence Number: 6087665
• Product Code: GFA
• UDI-Device Identifier: 10845854017722
• UDI-Public: (01)10845854017722(17)291119(10)1423689
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2026

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: C9911
• Device Lot Number: 1423689
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/18/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/19/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic