MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 2.5 MM DIAMETER LOCKING SCREW, 28 MM

Model Number 1405-1028

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The 28mm, 2.5mm diameter locking screw (1405-1028) is provided to customers within a sterile kit (sk-12) and marked single use.The udi reference is for the sterile kit, sk-12, that the product is distributed with.The device was not returned to the manufacturer.The dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported.Further investigation is in process.The company will supplement this mdr as necessary and appropriate.Device discarded.

Event Description

It was reported by a surgeon on (b)(6) 2016 that a screw that had been placed during a procedure on (b)(6) 2015, had presented broken during a six month post operative follow up visit (date unknown).The screw was originally placed from the base of the 1st to the 2nd metatarsals.The screw broke in the 2nd metatarsal, rather than in the inter-space and was causing pain, therefore a revision surgery was completed on an unknown date in (b)(6) 2016 to remove the screw.The tmt joint is fully fused/healed.

Manufacturer Narrative

The 28mm, 2.5mm diameter locking screw (1405-1028) is provided to customers within a sterile kit (sk-12) and marked single use.The udi reference is for the sterile kit, sk-12, that the product is distributed with.The device was not returned to the manufacturer.The dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported.The radiographic evidence submitted with the complaint was re-reviewed on 02/14/2017 and it was determined that the root cause of the screw breaking is most likely a result of non-union of the patient's bone after surgery due to screws being placed in areas and/or using a technique where fusion is not likely to occur.The device is intended for fusion and non-union is a known potential adverse event identified in the instructions for use, lbl 1405-9005 provided with the sterile kit.The company will supplement this mdr as necessary and appropriate.

• Brand Name: 2.5 MM DIAMETER LOCKING SCREW, 28 MM
• 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: 5864419
• MDR Text Key: 51728723
• Report Number: 3011623994-2016-00014
• 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
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1405-1028
• Device Lot Number: 18670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/08/2017; 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR