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 varus collapse of the neck a medical intervention was required.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms this literature review from india by rajendraprasad butala to compare the clinical and radiological results of the intertan nail and the trochanteric femoral nailing (tfn) in inter-trochanteric fractures by rajendraprasad butala.The conclusion of the study was that the intertan nail, while taking a little longer, had better outcomes with less degree of complications.C-283359, presented with a varus collapse of the neck and a medical intervention was required.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 providedfactors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.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: 9531884
• MDR Text Key: 173084414
• Report Number: 1020279-2019-04662
• 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: 04/15/2020

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention