MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM 2; PLATE

Model Number SK14

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/03/2023

Event Type  Injury  

Event Description

It was reported that after an initial bunion surgery on (b)(6) 2022, the medial plate and screws were removed in a revision surgery on (b)(6) 2023 due to a partial nonunion.Additional information indicates during removal, it was discovered the distal screw in the medial plate was loose.There was no other report of patient impact or injury as a result of this event.

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2022, the medial plate and screws were removed in a revision surgery on (b)(6) 2023 due to a partial nonunion.Additional information indicates during removal, it was discovered the distal screw in the medial plate was loose.The medial plate and screws were replaced and the partial nonunion was packed with bone graft.The surgeon is unsure as to the cause, but was not concerned with position.There was no elevatus and the intermetatarsal angle was maintained.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.There was no other report of patient impact or injury as a result of this event.The company will supplement this mdr as necessary and appropriate.

• Brand Name: LAPIPLASTY SYSTEM 2
• 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: 16287540
• MDR Text Key: 308704254
• Report Number: 3011623994-2023-00022
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006051
• UDI-Public: 00853114006051
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SK14
• Device Lot Number: 300273433
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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 Sex: Female