MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 26CM 125D RIGHT; NAIL, FIXATION, BONE

Model Number 71675523

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/03/2019

Event Type  Injury  

Event Description

It was reported that a female patient ((b)(6) years old) underwent a fracture around the distal screw after an intertan implant procedure.The dr.Thinks the diameter of the part under the screw head is wide, and the diameter of the drill is not fit for it.Xray and ct images are available.It is not known how long after implantation the fracture occurred.

• Brand Name: INTERTAN 10S 10MM X 26CM 125D RIGHT
• 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 TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9932951
• MDR Text Key: 186698744
• Report Number: 1020279-2020-01206
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 71675523
• Device Catalogue Number: 71675523
• Device Lot Number: 19DM19351
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1