MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 4.0MM FULLY THREADED SCREW

Model Number	SK38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery (b)(6) 2023, a broken screw was removed in a revision surgery on (b)(6) 2023.The tip of the broken screw was retained in the patient's bone.No other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery (b)(6) 2023, a broken screw was removed in a revision surgery on (b)(6) 2023.The tip of the broken screw was retained in the patient's bone.No other patient outcomes were reported as a result of this event.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined due to the device not being returned for evaluation.However, it is possible the device was subjected to excessive bending stresses leading to its breakage.The company will supplement this mdr as necessary and appropriate.
Additional Manufacturer Narrative
H6.Adverse event problem investigation conclusion: 4310 - cause cannot be traced to device.H10 update: it was reported that after an initial bunion surgery (b)(6) 2023, a broken screw was removed in a revision surgery on (b)(6) 2023.The broken screw was found upon further examination due to the patient's report of pain.The tip of the broken screw was retained in the patient's bone.Additional information indicates the patient was a large male and non-compliance was suspected.No other patient outcomes were reported as a result of this event.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.Although a number of factors could have contributed to what was reported, the most likely cause cannot be determined due to the device not being returned for evaluation.However, it is possible the patient's non-compliance post-op subjected the device to excessive bending stresses, which led to its breakage.The company will supplement this mdr as necessary and appropriate.

• Brand Name: 4.0MM FULLY THREADED SCREW
• Common Device Name: SCREW
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 17577320
• Report Number: 3011623994-2023-00207
• Device Sequence Number: 21072040
• Product Code: HWC
• UDI-Device Identifier: 00853114006303
• UDI-Public: 00853114006303
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 11/18/2024
• Device Model Number: SK38
• Device Lot Number: 300060189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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: 68 YR
• Patient Sex: Male