MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 4.0MM COMPRESSION SCREW SYSTEM - HEADLESS

Model Number	SK26
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2021, 8 screws, 2 plates, and 2 compression screws were removed on (b)(6) 2021 due to pain and both compression screws being loose.After the removal, the patient indicates the pain "is mostly gone".There was no other report of any patient impact or injury as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2021, one of three compression screws in the patient's big toe was removed on (b)(6) 2021 due to pain and being "too long" (mdr# 3011623994-2022-00008).On (b)(6) 2021, the patient underwent another procedure to remove the remaining hardware (mdr# 3011623994-2022-00011) due to pain and the other two compression screws being loose.No device was returned for evaluation.The patient indicated that upon hardware removal, there were no deficiencies or malfunctions found with any tmc device, but she believes the compression screws which were described as "rocking back and forth, hallowing out" her bone, were too large for her bones and implanted at an incorrect angle eventually resulting in stress fractures.Since the hardware was removed, the patient indicated that although she is still in physical therapy which is painful, the pain in her foot is mostly gone and her movement has improved.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined based on the available information.However, improper device selection or placement, and/or post-operative activity could potentially lead to loosening hardware.The instructions for use, lbl 1405-9056, identifies warnings related to postoperative care and the surgical technique, lbl 1405-9095, instructs on proper device selection and the proper method for inserting compression screws.The company will supplement this mdr as necessary and appropriate.

• Brand Name: 4.0MM 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: julia white ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 13552760
• Report Number: 3011623994-2022-00010
• Device Sequence Number: 20130310
• Product Code: HWC
• UDI-Device Identifier: 00853114006198
• UDI-Public: 00853114006198
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: SK26
• Device Lot Number: 34604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2020
• 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 Sex: Female