MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPATIALFRAME.COM SOFTWARE; MEDICAL COMPUTERS AND SOFTWARE

Catalog Number 71070401

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2020

Event Type  Injury  

Event Description

It was reported that during set up or inspection of taylor spatial frame software for a blount's case, 2 strut change outs for strut number 5 were not identified by the software.Change in surgical technique was required to complete the procedure.(procedure specifications: 25 deg varus, 17 deg apex ant, 5 short.Axial translation used.No sar was used.0.6 mm/day used for duration.14 day prescription resulted).

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, it was reported during set-up of the tsf software prior to patient¿s use, 2 struts out of 5 were not identified by the software.Based on the information provided, the surgeon was able to make a change in the surgical technique to complete the procedure.Since the was no report of delay or harm to the patient; no further clinical/medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to a very aggressive short term correction plan.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: SPATIALFRAME.COM SOFTWARE
• Type of Device: MEDICAL COMPUTERS AND SOFTWARE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10360423
• MDR Text Key: 201496912
• Report Number: 1020279-2020-03675
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71070401
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention