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

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

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  Injury  

Event Description

It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery due to a failed correction.No deficiencies/failures have been alleged/found with any tmc hardware and the patient was revised with non-tmc hardware.

Manufacturer Narrative

It was reported that after an initial bunion surgery, all hardware was removed in a revision surgery due to a failed correction and the patient was revised with non-tmc hardware.No devices were returned for evaluation.The device history records for all possible sk14 and sk12 used in the case were reviewed and no issues were identified during the manufacture or release of the devices that could have contributed to what was reported.Although a number of factors could have contributed to the removal of the hardware, based on the limited information available and unsuccessful attempts to obtain additional information, the most likely cause of what was reported cannot be determined.No malfunctions have been alleged/found with any tmc hardware, nor was it a determining factor for performing the revision surgery.The other devices explanted in the same revision surgery were also tmc devices which were reported in mdr 3011623994-2021-00065.The company will supplement this mdr as necessary and appropriate.

• Brand Name: LAPIPLASTY SYSTEM
• Type of Device: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer Contact: julia white ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 12807346
• MDR Text Key: 284511668
• Report Number: 3011623994-2021-00064
• Device Sequence Number: 1
• Product Code: HRS
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• 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
• Patient Sex: Female