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

Model Number 1405-10XX

Device Problem Missing Value Reason (3192)

Patient Problem Missing Value Reason (3192)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

The 2.5 mm diameter locking screws (1405-10xx) and 4 hole curved plates ((b)(4)) are provided to the customer 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 devices removed were not returned to the manufacturer for evaluation.There is not sufficient information to perform a detailed dhr review as the part and lot information is unknown.The root cause of the revision is related to the screw not being locked into the plate during the original surgery and the fact that the patient was unable to sufficiently avoid forefoot weight baring.This analysis is based on the information provided by the surgeon performing the original and revision surgery.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported 09/27/2016 by a sales representative that a revision was scheduled for (b)(6) 2016 on a patient that previously underwent a bunion surgery on (b)(6) 2016.The patient was not able to sufficiently avoid forefoot weightbearing, which resulted in the distal screw (unknown 1405-10xx) backing out.Additional information from the surgeon indicated that the screw that backed out was not originally locked into the plate as it was beyond the incision.This resulted in the base of the metatarsal translating slightly causing both plates to separate slightly from the metatarsal.Two plates ((b)(4)) and seven additional unknown screws were removed on (b)(6) 2016 which were a part of the same system.

• Brand Name: 2.5MM DIAMETER LOCKING SCREW
• 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: 6057591
• MDR Text Key: 58402397
• Report Number: 3011623994-2016-00025
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1405-10XX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: No
• 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