MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC AO HEXALOBULAR #8 TIP; DRIVER

Model Number	1405-2202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The available information indicates the tip of a #8 ao hexalobular tips broke off in the head of a screw, which was implanted in the patient's bone.A backup device was available to successfully complete the surgery.No other patient outcomes were reported.Although there was no adverse event reported or anticipated, a piece of a #8 ao hexalobular 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 the driving end of an ao driver tip broke off as the surgeon was inserting a screw.The detached portion of the ao driver tip was retained in the head of a screw, which was implanted in the patient.A backup device was available to successfully complete the surgery.No other patient outcomes were reported.The device was returned to the manufacturer for evaluation.The failure appeared to be the result of torsion, which is consistent with its designed use.The device history record was reviewed and no non-conformances or issues during the manufacture or release of the product were identified that could have contributed to the issue reported.Based on evaluation of the device and the available information, it is likely the device was not properly seated and/or excessive torque was applied to the device during use.This can lead to torsional failure which is consistent with the observed damage on the device.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.
Additional Manufacturer Narrative
D4.Model #: 1405-2202.

• Brand Name: AO HEXALOBULAR #8 TIP
• Common Device Name: DRIVER
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC; 100 palmetto park place; ponte vedra 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: kristine gates ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 17666551
• Report Number: 3011623994-2023-00222
• Device Sequence Number: 7124102
• Product Code: HXX
• UDI-Device Identifier: 00853114006624
• UDI-Public: 00853114006624
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/28/2023

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: 1405-2202
• Device Lot Number: AL22441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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 Sex: Unknown