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

Model Number	1405-2015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an olive wire broke off and was retained in the patient's bone during a bunion procedure on (b)(6) 2022.The case was completed successfully with no additional patient outcomes.
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) 2022.The device was not returned for evaluation.The udi referenced is for the sterile kit, sk14, the product is distributed within.The device history record was reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.Based on the available information, the most likely cause cannot be determined; however, it is possible the device broke due to impact with another device in the bone or was subjected to additional forces or bending stresses.A backup device was available to successfully complete the case with no additional patient outcomes.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.The company will supplement this mdr as necessary and appropriate.
Additional Manufacturer Narrative
D4: lot #: lb21410 d9: device available for evaluation?: yes, returned to manufacturer: 02-jun-2022 g3: date received by manufacturer: 02-jun-2022 h3: device evaluated by manufacturer?: yes, evaluation summary attached h6: type of investigation: 10 investigation findings: 3243 h10: the device was returned for evaluation and analysis confirmed the olive wire broke right where the threading meets the shaft of the device.The device history record was reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.Based on the available information, the most likely cause cannot be determined; however, it is possible the device broke due to impact with another device in the bone or was subjected to additional forces or bending stresses.The company will supplement this mdr as necessary and appropriate.

• Brand Name: 2MM X 40MM OLIVE WIRE WITH THREADED TIP
• Common Device Name: OLIVE WIRE
• 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: uriza shums ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 14434941
• Report Number: 3011623994-2022-00042
• Device Sequence Number: 17537778
• Product Code: HWE
• UDI-Device Identifier: 00853114006082
• UDI-Public: 00853114006082
• 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: 2022
• 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): 06/30/2022

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: 02/01/2025
• Device Model Number: 1405-2015
• Device Lot Number: LB21410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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 Age: 53 YR
• Patient Sex: Female