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 Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The 28 mm, 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.There was no report of any patient injury or plan for revision.After a similar event which resulted in a revision surgery was reported on mdr 3011623994_2016_00014, on (b)(6) 2016, it was identified that the issue reported in this complaint would be considered a malfunction that previously lead to a serious injury.The device was not returned to the manufacturer as it remains implanted.The lot specific detail was not provided however the associated device history records were reviewed and no issues were identified during the manufacturing and release of the devices that could have contributed to the problem reported.The most likely cause is unable to be determined at this time and the investigation is ongoing.The patient is asymptomatic and no revision is scheduled at this time.The company will supplement this mdr as necessary and appropriate.Device remains implanted.

Event Description

On 12/02/2016 a surgeon sent x-rays to the company identifying one broken 28 mm screw (1405-1028) between the first and second metatarsal; implanted on an original surgery date of (b)(6) 2016.The surgeon indicated that the patient was asymptomatic and that no revision surgery was planned.

Manufacturer Narrative

The 28 mm, 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.There was no report of any patient injury or plan for revision.After a similar event which resulted in a revision surgery was reported on mdr 3011623994_2016_00014, on 08/10/2016, it was identified that the issue reported in this complaint would be considered a malfunction that previously lead to a serious injury.The device was not returned to the manufacturer as it remains implanted.The lot specific detail was not provided however the associated device history records were reviewed and no issues were identified during the manufacturing and release of the devices that could have contributed to the problem reported.The patient is asymptomatic and no revision is scheduled at this time.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: 6217012
• MDR Text Key: 63690870
• Report Number: 3011623994-2017-00002
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 1405-1028
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 01/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• 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