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

Model Number 1405-2202

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

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.Although there was no adverse event reported or anticipated, a piece of an ao 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.

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.No device was 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 driver tips 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.

• Brand Name: AO HEXALOBULAR #8 TIP
• Type of Device: DRIVER
• 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: kristine gates ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 18421973
• MDR Text Key: 331678516
• Report Number: 3011623994-2023-00348
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00853114006624
• UDI-Public: 00853114006624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A-CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2023

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
• Device Operator: Health Professional
• Device Model Number: 1405-2202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1