MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC LAPIPLASTY 4.0MM FULLY THREADED SCREWS - LONG

Model Number	SK38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fully threaded screw broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2023.There was no report of delay, nor impact or injury to the patient as a result of the event.Although this malfunction has not resulted in a revision surgery to date in this event, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, a mdr will be filed to ensure full compliance with 21 cfr part 803.
Additional Manufacturer Narrative
It was reported that a fully threaded screw broke off and was retained in the patient's bone during a bunion procedure on 11-09-2023.The head and the top half of the screw were removed.The rest of the screw remains implanted in the patient.There was no report of delay, nor impact or injury to the patient as a result of the event.The device was not returned for evaluation.The device history records were reviewed, and no issues were identified during the manufacture and release of the device 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 the breakage.Although this malfunction has not resulted in a revision surgery to date in this event, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, a mdr will be filed to ensure full compliance with 21 cfr part 803.

• Brand Name: LAPIPLASTY 4.0MM FULLY THREADED SCREWS - LONG
• 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: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 18288994
• Report Number: 3011623994-2023-00317
• Device Sequence Number: 6189490
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2025
• Device Model Number: SK38
• Device Lot Number: 300241755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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
• Patient Sex: Unknown