MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC; OLIVE WIRE

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a olive wire drill bit broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2023.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 the mdr in an abundance of caution and to ensure full compliance with 21 cfr part 803.
Additional Manufacturer Narrative
It was reported that the tip of a olive wire drill bit broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2023.The olive wire is provided to customers within a sterile kit (sk34) and marked single use.The udi referenced is for the sterile kit, sk34, that the product is distributed within.The device was not returned for evaluation.Device specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for possible olive wire drills utilized in surgery were reviewed and no non-conformances or issues during the manufacture or release of the products were identified to date 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.

• 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 32081 ; 9043735940
• MDR Report Key: 17693379
• Report Number: 3011623994-2023-00226
• Device Sequence Number: 12257531
• Product Code: HWE
• UDI-Device Identifier: 00853114006273
• UDI-Public: 00853114006273
• 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): 09/06/2023

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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: 42 YR
• Patient Sex: Male