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, li 2019, "comparison of internal fixation with gamma3 long nails and intertan nails in the treatment of seinsheimer type v subtrochanteric femoral fractures in elderly patients" it was reported that the patient presented a malunion.It is unknown how the adverse event was treated.

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 complaint was reported from the literature review, ¿comparison of internal fixation with gamma3 long nails and intertan nails in the treatment of seinsheimer type v subtrochanteric femoral fractures in elderly patients.¿ based on the literature review, the aim of this study was to clinically compare the therapeutic effects of internal fixation using a third-generation gamma long nail with that of intertan in the treatment of seinsheimer type v subtrochanteric femoral fractures in elderly patients.Subtrochanteric fracture is an orthopedic injury with a high rate of nonunion and failure of internal fixation and in the geriatric populations there has been a continuous increase in the incidence of subtrochanteric fractures.In this study a total of 12 patients with seinsheimer type v closed subtrochanteric fractures were surgically treated with the intertan intramedullary nail system.The results of the study showed that patients in the gamma long nail group had shorter operation time and less intraoperative blood loss when compared with those in the intertan group which was attributed to the longer operation time.There were no significant differences between the groups in the postoperative complications and fracture healing time.During the studying it was reported that the patient presented a malunion and it is unknown how the adverse event was treated.After three requests no individual clinical information has been provided for inclusion in this medical investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Factors 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: 9535441
• MDR Text Key: 173218066
• Report Number: 1020279-2019-04717
• 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: 04/17/2020

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention