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

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 02/06/2020

Event Type  Injury  

Event Description

It was reported that a trigen gold screw broke early after implantation.It is unknown if a revision surgery was performed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our clinical/medical team noted: this complaint from the united states reports that a trigen gold screw broke early during the implantation of a meta-tan nail to repair a femoral shaft fracture on (b)(6) 2019.No clinical/medical documentation or x-rays have been provided to support this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The impact to the patient cannot be determined with the available information.The screw is implantable, micromotion or migration cannot be ruled out.Without the product and no product information we could not complete the history, information for use or risk management.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRAUMA IMPLANT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9714996
• MDR Text Key: 179547916
• Report Number: 1020279-2020-00568
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention