MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC LAPIPLASTY SPEEDPLATE QUAD 28MM RAPID COMPRESSION IMPLANT; STAPLE

Model Number SK48

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

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

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2023 due to charcot foot.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.Additional information indicates the patient is diabetic, has an uncontrolled a1c and has poor bone quality.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, it is possible that the patient's noncompliance, poor bone quality and diabetes 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 device explanted in the same revision surgery was reported in 3011623994_2023__00321.

Event Description

It was reported that after a surgery to repair 2 fractures unrelated to tmc devices on (b)(6)2023, all tmc hardware utilized to repair the 2 fractures had to be removed on (b)(6)2023 due to charcot and non-compliance.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.

• Brand Name: LAPIPLASTY SPEEDPLATE QUAD 28MM RAPID COMPRESSION IMPLANT
• Type of Device: STAPLE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 18297511
• MDR Text Key: 330112677
• Report Number: 3011623994-2023-00320
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222645
• 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: 12/08/2023

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: SK48
• Device Lot Number: 300470542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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: 65 YR
• Patient Sex: Female