MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN EXTERNAL FIXATOR PIN; PIN, FIXATION, THREADED

Catalog Number UNKN02300106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Skin Infection (4544)

Event Date 09/28/2018

Event Type  Injury  

Event Description

On the literature article named "combined intramedullary nail coated with antibiotic-containing cement and ring fixation for limb salvage in the severely deformed, infected, neuroarthropathic ankle", it was reported that patient number 6 suffered from a superficial pin site infection that were treated with oral antibiotics and local pin care.The patient´s outcome is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.The images provided were reviewed and a relationship, if any, between the device and the reported incidents could not be corroborated.The clinical/medical investigation concluded that, the data presented in the literature article, "combined intramedullary nail coated with antibiotic-containing cement and ring fixation for limb salvage in the severely deformed, infected, neuroarthropathic ankle", did not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.Based on the information provided, patient number 6 suffered from a superficial pin site infection treated with oral antibiotics and local pin care.However, the patient´s outcome is unknown.Therefore, the root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: UNKN EXTERNAL FIXATOR PIN
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12096605
• MDR Text Key: 259357387
• Report Number: 1020279-2021-05559
• Device Sequence Number: 1
• Product Code: JDW
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02300106
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention