MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Type  Injury  

Event Description

It was reported that the patient participated in a intramedullary nailing study, after surgery the patient developed a persistent infection and eventually required a below-knee amputation.

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 is a complaint from a literature review, ¿chopart amputation¿reconstruction for severe foot crush injury¿ [the bone joint journal 2018;100-b:1359-63], which reported the outcomes of a technique of soft tissue coverage (ttc arthrodesis by retrograde im nailing with flaps/ssg) and chopart amputation for severe crush injuries of the forefoot.The overall results were that this treatment method (along with soft-tissue coverage before fixation) may be a valuable alternative for treating severely crushed foot injuries.It was reported that a patient experienced a ¿persistent infection and eventually required a below-knee amputation.¿( c-0279070).No individual medical documentation was provided.Without supporting clinical/medical documents, a thorough investigation could not be performed.The patient impact beyond the reported persistent infection and eventual below the knee amputation could not be determined.Should information become available the clinical/medical assessment may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Infection is a potential complication associated with any surgery.Some potential probable causes could include contamination, patient reaction or a post-operative healing issue.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.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: TRAUMA IMPLANT
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9390494
• MDR Text Key: 168441169
• Report Number: 1020279-2019-04192
• Device Sequence Number: 1
• Product Code: MDM
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• 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: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention