MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPATIALFRAME.COM SOFTWARE; SOFTWARE FOR DIAGNOSIS/TREATMENT

Catalog Number 71070401

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device, used for treatment was not returned for evaluation, reporting event could not be confirmed.A complaint is for the iadjust mobile application, which is a component of taylor spatial frame software, therefore no devices will be returned for evaluation.No screenshots or log files, used in treatment, were provided for review.There is no information that would suggest the device/software failed to meet specifications.A relationship, between the device/software and the reported incident could be corroborated.This event has been communicated to the tsf product development engineer for their consideration.No further investigation is warranted for this event.Possible cause could include but is not limited to software not programmed correctly.Based on this investigation, the need for corrective action is not indicated.If additional information is received, the complaint will be re-opened.This investigation is considered closed.

Event Description

It was reported that the surgeon wanted to use software for treatment of the taylor spatial frame software.The surgeon navigated to www.Spatialframe.Com at the beginning of a surgery case, because the surgeon wanted to use the chronic mode in the software to ensure he was building an optimized frame.Both the surgeon and the sales representative were unable to login.The incident occurred prior to logging in.The login screen was not available.There was a delay greater than 30 minutes for the adverse event.No injury reported.

Manufacturer Narrative

Investigation results: the device, used for treatment was not returned for evaluation, reporting event could not be confirmed.A complaint is for the iadjust mobile application, which is a component of taylor spatial frame software, therefore no devices will be returned for evaluation.No screenshots or log files, used in treatment, were provided for review.There is no information that would suggest the device/software failed to meet specifications.A relationship, between the device/software and the reported incident could be corroborated.This event has been communicated to the tsf product development engineer for their consideration.No further investigation is warranted for this event.Possible cause could include but is not limited to software not programmed correctly.Based on this investigation, the need for corrective action is not indicated.If additional information is received, the complaint will be re-opened.This investigation is considered closed.

• Brand Name: SPATIALFRAME.COM SOFTWARE
• Type of Device: SOFTWARE FOR DIAGNOSIS/TREATMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11580344
• MDR Text Key: 242672762
• Report Number: 1020279-2021-02412
• Device Sequence Number: 1
• Product Code: OSN
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71070401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1