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 Renal Failure (2041)

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 4 suffered from antibiotic-induced acute renal failure.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 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 aged article reported, "the use of a multiplanar, multi-axis external fixator to achieve knee arthrodesis in worst case scenario: a case series", it was reported that, patient 4 suffered from antibiotic-induced acute renal failure.However, 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.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.Some probable causes for this event could include, but are not limited to post operative condition o patient reaction.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.We consider this investigation closed.

• 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: 12097237
• MDR Text Key: 259360616
• Report Number: 1020279-2021-05576
• 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: 08/30/2021

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: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 82 YR