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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, butala, "comparative study between intertan and trochanteric femoral nailing (tfn) in inter-trochanteric fractures: a prospective study of functional and radiological outcomes" it was reported that the patient presented a lateral cortex fracture of the proximal femur a medical intervention was required.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this literature review from india was to compare the clinical and radiological results of the intertan nail and the trochanteric femoral nailing (tfn) in inter-trochanteric fractures.The conclusion of the study was that the intertan nail, while taking a little longer, had better outcomes with less degree of complications.(b)(4), presented with a lateral cortex fracture of the proximal femur and required a medical intervention.No individual specific medical documentation was provided.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 information provided.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include surgical technique or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.

• 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: 9531922
• MDR Text Key: 173101588
• Report Number: 1020279-2019-04663
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention