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, sellan, "short versus long intertan fixation for geriatric intertrochanteric hip fractures: a multicentre head-to-head comparison" it was reported that the patient was using a long nail and needed blood transfusion postoperatively.

Manufacturer Narrative

It was reported from a literature review that the patient was using a long nail and needed blood transfusion postoperatively.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 postoperative blood loss was found to be significantly higher in the long it group without a significant influence on the number of patients requiring transfusion or average units transfused.These cases did not involve a device failure or any failure due to a smith and nephew implant.The root cause of the blood transfusion was reported as a common medical complication after a hip fracture.The patient impact beyond the reported postoperative blood transfusion cannot be determined.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.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.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: 9545730
• MDR Text Key: 173767015
• Report Number: 1020279-2020-00087
• 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: 04/16/2020

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: 01/03/2020
• Supplement Dates Manufacturer Received: 04/13/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization