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

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, sellan, "short versus long intertan fixation for geriatric intertrochanteric hip fractures: a multicentre head-to-head comparison" it was reported that the patient that was using the long nail presented a periprosthetic fracture.It is unknown how this adverse event was treated.

Manufacturer Narrative

It was reported from a a literature review that the patient using the long nail presented a periprosthetic fracture.It is unknown how this adverse event was treated.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.A medical analysis noted that the study recorded the prevalence of peri-implant fracture visible on postoperative plain radiographs out to 1-year postoperatively.Short intramedullary devices have been shown to have a higher incidence of periprosthetic fracture than long devices.These cases did not identify how the fractures occurred or how they were treated therefore the root cause cannot be concluded.The patient impact beyond the reported periprosthetic fracture cannot be determined.Based on this investigation, the need for corrective action is not indicated.The potential root causes could include but are not limited to healing complications (nonunion, infection, etc.) that weakened bone, impeded fixation, or otherwise led to premature fracture.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• 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: 9545161
• MDR Text Key: 173765457
• Report Number: 1020279-2020-00068
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization