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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. 2.5 MM DIAMETER LOCKING SCREW, 28 MM
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TREACE MEDICAL CONCEPTS, INC. 2.5 MM DIAMETER LOCKING SCREW, 28 MM Back to Search Results
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 Date 12/21/2016
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.Based on the comments from the revising surgeon and evaluation of the x-rays, it is likely the screw broke as result of fatigue from placing the screw too distally on the metatarsals.The company will supplement this mdr as necessary and appropriate.Device not returned.
 
Event Description
A request was received by an employee of the company on 12/19/2016 for instruments to utilize in an upcoming revision surgery planned for (b)(6) 2016.The revising surgeon was not the same surgeon as the original surgery completed on (b)(6) 2016.The revision surgery was completed on (b)(6) 2016 and unknown implants (screws and/or plates)were removed as a result of a broken screw that was placed in the original surgery between the metatarsals (m1-m2).The surgeon also commented that there was a 2nd metatarsal fracture and that the m1-m2 screw had been placed too distally likely causing the fatigue fracture of the screw.
 
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.Based on the comments from the revising surgeon and evaluation of the x-rays, it is likely the screw broke as result of fatigue from placing the screw too distally on the metatarsals.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, (b)(4) provided with the sterile kit.The company will supplement this mdr as necessary and appropriate.
 
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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 Key6268780
MDR Text Key65455479
Report Number3011623994-2017-00007
Device Sequence Number1
Product Code HWC
UDI-Device Identifier0853114006006
UDI-Public(01)0853114006006
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143717
Number of Events Reported1
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
Date FDA Received01/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model Number1405-1028
Device Lot NumberHG15302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age26 YR
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