MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS TMC SPEEDPLATE ANATOMIC; STAPLE

Model Number SK50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  Injury  

Event Description

It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2024 due to over-correction.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2024 due to over-correction.The site was revised with tmc hardware.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, additional information indicates it is possible that over tightening of the positioner during the original surgery could have contributed to what the patient experienced.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with the placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.Additional tmc hardware explanted in the same revision surgery was reported in mfr report#: 3011623994-2024-00046.

• Brand Name: TMC SPEEDPLATE ANATOMIC
• Type of Device: STAPLE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 18862448
• MDR Text Key: 337182252
• Report Number: 3011623994-2024-00045
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810111221788
• UDI-Public: 00810111221788
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K232387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: SK50
• Device Lot Number: 300498553
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male