MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC 2MM X 40MM OLIVE WIRE

Model Number	1405-2015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a threaded olive wire broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2023.A back-up device was available to successfully complete the case.There was no report of delay, nor impact or injury to the patient as a result of the event.
Additional Manufacturer Narrative
It was reported that the tip of a threaded olive wire 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.The olive wire is provided to customers within a sterile kit (sk12) and marked single use.The udi referenced is for the sterile kit, sk12, that the product is distributed within.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.A backup device was used to successfully complete the case with no additional patient outcomes.The most likely cause cannot be determined based on the available information; however, it is possible the technique utilized applied additional bending forces to the device, or it broke due to impact with another device.The product is manufactured with implant grade material and the case was successfully completed with no report of impact/injury or case delay, nor have any adverse events previously been reported as a result of this failure to date.Although the company has determined that the subject event in this mdr is unlikely to result in a serious injury if it recurred, the company has decided to file this mdr in an abundance of caution and to ensure full compliance with 21 cfr part 803.The company will supplement this mdr as necessary and appropriate.

• Brand Name: 2MM X 40MM OLIVE WIRE
• Common Device Name: OLIVE WIRE
• 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: 18271882
• Report Number: 3011623994-2023-00311
• Device Sequence Number: 11751243
• Product Code: HWE
• UDI-Device Identifier: 00853114006006
• UDI-Public: 00853114006006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A-CLASS I
• 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): 12/05/2023

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 Model Number: 1405-2015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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 Age: 35 YR
• Patient Sex: Female