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

Model Number SK14

Device Problem Break (1069)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2020, a broken dorsal plate and corresponding screws were removed in a revision surgery on (b)(6) 2020.The surgeon revised the site with tmc hardware.The device was returned to the manufacturer for evaluation.Analysis of the device confirms the reported issue of a broken plate.The device history records for all devices intended to be implanted (sk14) were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.A number of factors could have contributed to the breakage of the plate, however information from the surgeon indicates the patient was non-compliant.The patient's non-compliance likely subjected excessive bending stresses to the plate which led to its breakage.The instructions for use identify warnings related to postoperative care.The company will supplement the mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery on (b)(6) 2020, a broken dorsal plate and corresponding screws were removed in a revision surgery on (b)(6) 2020.The surgeon revised the site with tmc hardware.There was no other report of any patient impact or injury as a result of this event.

• Brand Name: LAPIPLASTY SYSTEM 2
• 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: uriza shums ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 10646527
• MDR Text Key: 210375579
• Report Number: 3011623994-2020-00029
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006051
• UDI-Public: (01)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: 10/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2022
• Device Model Number: SK14
• Device Lot Number: 19110013553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• 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: 60 YR