MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; NAIL, FIXATION, BONE

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 03/06/2020

Event Type  Injury  

Event Description

It was reported that there was an incomplete bone fracture around the distal low profile screw after or during intertan operation.An intertan 26 cm nail and trigen low profile screw were used.No other complications were reported.

• Brand Name: TRAUMA IMPLANT
• 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: 9881112
• MDR Text Key: 185101568
• Report Number: 1020279-2020-01014
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/07/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 12/07/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention