MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 2.5MM COMPRESSION SCREW SYSTEM - HEADLESS

Model Number	SK20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after initial bilateral bunion surgeries on (b)(6) 2020 (right foot) and (b)(6) 2020 (left foot), all hardware was removed in a revision surgery on (b)(6) 2022 due to pain.No devices were returned to the manufacturer for evaluation.The device history records for all devices intended to be implanted were reviewed ((b)(4)) and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The other devices explanted in the same revision surgery were also tmc devices which were reported in mdrs 3011623994-2022-00050, 3011623994-2022-00051, 3011623994-2022-00052 and 3011623994-2022-00053.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined.Based on the available information, there have been no deficiencies or failure alleged/found against any tmc device, nor were there any reported issues with the initial placement or healing of the surgical site.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
It was reported that after initial bilateral bunion surgeries on (b)(6) 2020 (right foot) and (b)(6) 2020 (left foot), all hardware was removed in a revision surgery on (b)(6) 2022 due to pain.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device or healing of the surgical site.

• Brand Name: 2.5MM COMPRESSION SCREW SYSTEM - HEADLESS
• Common Device Name: SCREW
• 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: 14647316
• Report Number: 3011623994-2022-00054
• Device Sequence Number: 14876216
• Product Code: HWC
• UDI-Device Identifier: 00853114006112
• UDI-Public: 00853114006112
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: SK20
• Device Lot Number: 19090013428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female