MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD TROCH PLATE; NAIL, FIXATION, BONE

Catalog Number OR30-DUMMY2

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

It was reported that the accord troch plate broke in 2 pieces inside the patient.The femur of the patient broke too.

• Brand Name: ACCORD TROCH PLATE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis NC 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 11256289
• MDR Text Key: 229547986
• Report Number: 1020279-2021-00773
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OR30-DUMMY2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention