MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TAYLOR SPATIAL FRAME EXFIX DEV; PIN, FIXATION, THREADED

Catalog Number UNKN02300100

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

Patient Problem Tissue Breakdown (2681)

Event Date 01/01/2013

Event Type  Injury  

Event Description

On the literature article named "the use of a multiplaner, multi-axis external fixator to achieve knee arthrodesis in worst case scenario: a case series", it was reported that, patient 7 suffered from wound breakdown.It was not reported how the adverse event was addressed.The outcome of the patient is unknown.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.The images provided were reviewed and could not confirm the stated failure mode.A relationship, if any, between the device and the reported incidents could not be corroborated.The clinical/medical investigation concluded that, the article provided is a study involving 7 patients following implantation tsf after a chronic history of infections, secondary to (on average 3) failed tka procedures which warranted arthrodesis as a last resort to stabilize affected limb.The data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all the attached images.Therefore, no further interpretation of the attached images are required.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 are not limited to traumatic injury, 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 TAYLOR SPATIAL FRAME EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12097242
• MDR Text Key: 259359316
• Report Number: 1020279-2021-05577
• 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: 09/14/2021

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: UNKN02300100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention