MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS EXTENDED LENGTH SCREW DRIVER - HEXALOBULAR #8 NON-CANNULATED; SCREWDRIVER

Model Number	02-00155
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
Additional Manufacturer Narrative
It was reported that during an initial bunion surgery, the tip of an ao driver tip broke off in the head of the dorsal screw which was implanted in the patient's bone.No other patient outcomes were reported as a result of this event.No devices were 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 kits 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, it is likely that excessive torque was applied to the device during use, which can lead to torsional failure.The surgical technique includes multiple statements regarding the proper method for inserting screws into a plate.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.
Event or Problem Description
It was reported that during an initial bunion surgery,the tip of an ao driver tip broke off in the head of the dorsal screw which was implanted in the patient's bone.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.

• Brand Name: EXTENDED LENGTH SCREW DRIVER - HEXALOBULAR #8 NON-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: 20898705
• Report Number: 3011623994-2024-00238
• Device Sequence Number: 9053774
• Product Code: HXX
• UDI-Device Identifier: 00810111222655
• UDI-Public: (01)00810111222655
• 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: 02-00155
• 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 Age: 73 YR
• Patient Sex: Male