MAUDE Adverse Event Report: CONMED RTS; PROSTHESIS, TOE, CONSTRAINED, POLYMER

Catalog Number	M30 SE010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
This complaint was created due to the receipt of ansm reference (b)(4) on 14jan2026.The current complaint database has been researched for this event and there were no findings.The report was found to be written against device, m30 se010, rts flexible 1st mpj implant with grommets, size 1, which was used during an unknown procedure on (b)(6) 2026, where the device was implanted into the patient.Then on (b)(6) 2026 that device was explanted because it needed replacement as the device had broken.The report stated that the patient underwent prolonged hospitalization.Further assessment has been requested; however, a response has not been received to date.This report is being raised due to the reported injury of secondary surgery to remove implanted device.
Event or Problem Description
This complaint was created due to the receipt of ansm reference (b)(4) on 14jan26.The current complaint database has been researched for this event and there were no findings.The report was found to be written against device, m30 se010, rts flexible 1st mpj implant with grommets, size 1, which was used during an unknown procedure on (b)(6) 2025, where the device was implanted into the patient.Then on (b)(6) 2026 that device was explanted because it needed replacement as the device had broken.The report stated that the patient underwent prolonged hospitalization.Further assessment has been requested; however, a response has not been received to date.This report is being raised due to the reported injury of secondary surgery to remove implanted device.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.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 one complaint, regarding one 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 that patients should be made aware of the increased potential for device failure when excessive demands are made upon it.Strenuous loading, excessive mobility, and articular instability all may lead to accelerated wear and eventual failure by loosening, fracture, or dislocation of the device.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: RTS
• Common Device Name: PROSTHESIS, TOE, CONSTRAINED, POLYMER
• Manufacturer (Section D): CONMED; 525 french rd.; utica NY 13502
• Manufacturer (Section G): IN2BONES USA, LLC; 7750a trinity rd; cordova TN 38018
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 24143864
• Report Number: 3011580264-2026-00002
• Device Sequence Number: 8887735
• Product Code: KWH
• UDI-Device Identifier: 00817906020007
• UDI-Public: 00817906020007
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: M30 SE010
• Device Lot Number: 9JHRA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic