MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

In a scientific publication, mekhail et al., "bone transport in the management of posttraumatic bone defects in the lower extremity" it was reported that following an ilizarov external fixation procedure to treat a lower extremity injury, the patient presented forefoot gangrene and an angiogram demonstrated peripheral vascular disease.The patient underwent femoropopliteal bypass and tarsometatarsal amputation.Later, there was a deep infection and persisting pain, so a transtibial amputation was performed.

Manufacturer Narrative

It was reported from a literature review from the paper: 'bone transport in the management of posttraumatic bone defects in the lower extremity" by mekhail et al., that the patient presented forefoot gangrene and an angiogram demonstrated peripheral vascular disease.The patient underwent femoropopliteal bypass and tarsometatarsal amputation.Later, there was a deep infection and persisting pain, so a transtibial amputation was performed.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.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The paper was published in 2004.The cause of the reported event was stated as deep infection.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: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9933722
• MDR Text Key: 186730583
• Report Number: 1020279-2020-01037
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 70 YR