MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC 1.3/1.6 SQUARE DRIVER

Model Number 1405-2127

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The driver is provided to customers within a sterile kit (sk12) and marked single use.The udi referenced is for the sterile kit, sk12, the product is distributed within.The device history record was reviewed and no issues during the manufacture or release of the product were identified that could have contributed to the problem reported.The most likely cause cannot be determined due to the device not being returned, however based on similar complaints where the device has been returned, the likely cause of the tip of the driver breaking off is due to applying excessive torque to the driver after the screw was completely seated.The surgical technique includes a statement regarding the proper method for inserting screws into a plate: "caution: use care not to over-tighten once the screw head locks into the plate, as this can result in stripping of the screw head or deforming the driver tip." 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 Description

During a bunion procedure on (b)(6) 2019, the tip of the driver (1405-2127) broke off and was retained in the head of the screw, which was implanted in the patient.A backup device was available to successfully complete the surgery.No other patient outcomes were reported.

• Brand Name: 1.3/1.6 SQUARE DRIVER
• Type of Device: DRIVER
• 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: 9530275
• MDR Text Key: 219577450
• Report Number: 3011623994-2019-00062
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00853114006006
• UDI-Public: (01)00853114006006
• 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: 12/30/2019

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: 1405-2127
• Device Lot Number: DM18403
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1