MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. TMC SPEEDMTP; SCREW, FIXATION, BONE

Model Number	SK58
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While in operation room, surgeon was drilling, pulled out drill but tip of drill bit (1.6mm) was still in foot.Flat plate taken, radiologit to read prior to closure, surgeon unable to remove tip of drill bit; tip left in place, wound irrigated and closed.

• Brand Name: TMC SPEEDMTP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 100 palmetto park place; ponte vedra FL 32081
• MDR Report Key: 24741272
• Report Number: 24741272
• Device Sequence Number: 18319789
• Product Code: HWC
• UDI-Device Identifier: 00810111223508
• UDI-Public: (01)00810111223508
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2026
• Report Date (Section F): 03/19/2026

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 Model Number: SK58
• Device Catalogue Number: SK58
• Device Lot Number: 300745815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/19/2026