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

Model Number SK14

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that approximately 7 months after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2020 due to what the patient believed was causing nerve irritation and medial swelling.Upon removal, the surgeon found no failure with any of the hardware and indicated the initial correction appeared "perfect" with the intended bones completely fused/healed.Although the surgeon stated that the implanted hardware was not a contributing factor to what the patient was experiencing, he was unable to determine the source/cause of the nerve irritation and medial swelling.The hardware was removed along with adding amniotic graft tissue to the incision site to aid in post-surgical healing.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device or healing of the surgical site.The surgeon stated the patient reported the site is currently still swollen, but otherwise is "much improved".The device was not returned to the manufacturer for evaluation, as it was discarded.Device specific product and lot information was not available, therefore a review of device history records was not able to be performed.However, all non-conformances for lapiplasty system 2 (sk14) were reviewed and no non-conformances or issues during the manufacture or release of the product were identified to date that could have contributed to what was reported.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported that approximately 7 months after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2020 due to what the patient believed was causing nerve irritation and medial swelling.Upon removal, the surgeon found no failure with any of the hardware and indicated the initial correction appeared "perfect" with the intended bones completely fused/healed.Although the surgeon stated that the implanted hardware was not a contributing factor to what the patient was experiencing, he was unable to determine the source/cause of the nerve irritation and medial swelling.The hardware was removed along with adding amniotic graft tissue to the incision site to aid in post-surgical healing.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device or healing of the surgical site.The surgeon stated the patient reported the site is currently still swollen, but otherwise is "much improved".

• 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
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra, fl
• Manufacturer Contact: uriza shums ; 203 fort wade road, suite 150; ponte vedra, fl ; 3735940134
• MDR Report Key: 10195433
• MDR Text Key: 197975327
• Report Number: 3011623994-2020-00012
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SK14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• 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 Age: 51 YR