MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS TMC AO HEXALOBULAR #8 TIP CANNULATED; SCREWDRIVER

Model Number	1405-2204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial bunion surgery, the tip of the driver broke off and remained in the head of the most distal screw during insertion.No other patient outcomes were reported as a result of this event.Although there was no adverse event reported or anticipated, a piece of a driver tip is not intended to be implanted, therefore the company has chosen to file a mdr to ensure full compliance with 21 cfr part 803.
Additional Manufacturer Narrative
It was reported that during an initial bunion surgery, the tip of the driver broke off and remained in the head of the most distal screw during insertion.No other patient outcomes were reported as a result of this event.Although no devices were returned for evaluation, photographic evidence was reviewed and confirmed that the failure appeared to be the result of torsion, which is consistent with its designed use.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 devices 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.The most likely cause cannot be determined due to the device not being returned.However, based on available information the most likely cause of the reported issue is consistent with user error, which resulted in the inappropriate device being selected for use.The reported application of the device is contrary to its intended use, as the screws contained in the kit used for the surgery (sk39) does not support the required use of a k-wire through the cannulation of this device.This can lead to torsional failure which is consistent with the observed damage on the device.The instructions for use and surgical technique include multiple statements regarding proper device.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: TMC AO HEXALOBULAR #8 TIP CANNULATED
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 20898716
• Report Number: 3011623994-2024-00239
• Device Sequence Number: 15689117
• Product Code: HXX
• UDI-Device Identifier: 00853114006631
• UDI-Public: (01)00853114006631
• 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: 2024
• 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): 12/10/2024

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: 1405-2204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female