MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM; PLATE

Model Number SK12

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 01/12/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2023 due to a screw that was slightly backing out.Additional information indicates the surgeon noticed the most proximal screw in the medial plate had started to back out and given the patient had fully healed, the surgeon and patient chose to remove the hardware.There was no other report of any patient impact or injury as a result of this event.No devices were returned to the manufacturer for evaluation.Device specific information was not available; therefore, a review of device history records was not able to be performed.However, non-conformance reports for all possible kits utilized in surgery were reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.Based on the available information, the most likely root cause cannot be determined due the device not being returned for evaluation.However, it is possible the initial placement of the screw and/or post-operative activity of the patient led to loosening and an eventual backing out of the screw.The instructions for use identifies warnings related to postoperative care and the surgical technique instructs on the proper method for inserting screws.The company will supplement the mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2023 due to a screw that was backing out.There was no other report of any patient impact or injury as a result of this event.

• Brand Name: LAPIPLASTY SYSTEM
• Type of Device: PLATE
• 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: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 16359157
• MDR Text Key: 309366343
• Report Number: 3011623994-2023-00028
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006006
• UDI-Public: 00853114006006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192504
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SK12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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