MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 2.5MM DIAMETER LOCKING SCREW 14MM

Model Number 1405-1014

Device Problem Missing Value Reason (3192)

Patient Problem Missing Value Reason (3192)

Event Date 04/28/2016

Event Type  Injury  

Manufacturer Narrative

The 14mm, 2.5mm diameter locking screw (1405-1014) is provided to customers within a sterile kit (sk-12) and marked single use.The udi referenced is for the sterile kit, sk-12, that the product is distributed within.The device was not returned to the manufacturer for evaluation as it was discarded.The dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported.The root cause of the revision is related to the screw backing out of the plate, which was most likely a result of the screw not being properly seated during original implantation.The analysis is based on feedback collected from the surgeon at the time the event was reported.Further investigation is in process.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported on 04/12/2016 that a patient that previously underwent a mtp procedure was scheduled for a revision surgery on (b)(6) 2016 due to a screw backing out of the plate.The screw (1405-1014) was removed on (b)(6) 2016 and another screw (1405-1014) was implanted.The explanted device was discarded.No other devices were removed during the revision surgery.

• Brand Name: 2.5MM DIAMETER LOCKING SCREW 14MM
• Type of Device: SCREW
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 3107 sawgrass village circle; ponte vedra beach FL 32082
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 3107 sawgrass village circle; ponte vedra beach FL 32082
• Manufacturer Contact: rachel osbeck ; 3107 sawgrass village circle; ponte vedra beach, FL 32082 ; 9043735940
• MDR Report Key: 5669250
• MDR Text Key: 45573045
• Report Number: 3011623994-2016-00007
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 0853114006006
• UDI-Public: (01)0853114006006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1405-1014
• Device Lot Number: HG15203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR