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

Catalog Number 71075401

Device Problem Computer Software Problem (1112)

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

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during an internal fixation procedure, the physician was trying to program in the smart tsf.Com a proximal reference case after building a frame with a short proximal ring block.The physician saw 4 dots in 3 arms of the beacon, but the software could not detect the beacon.Physician decided to use the manual mode instead.Surgery was resumed, without any delay, with a back-up device.Patient was not harmed.

Manufacturer Narrative

This complaint subject is the taylor spatial frame software; therefore, no devices will be returned for evaluation.The pictures provided were reviewed and could not confirm the detection failure.The clinical/medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.It was stated that the patient was not harmed in any way.Should any additional clinical information be provided, this complaint will be re-evaluated.A review of complaint history of the previous 12 months revealed similar events for the listed device, 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.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.It is important to meet the picture requirements, noticing that software cannot detect a sphere if another object overlaps the sphere.Software changes are in process to reduce detection algorithm requirements.Factors that could contribute to the reported event include software algorithm requirements.The contribution of the software to the reported event could not be corroborated.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: SMART TSF.COM
• Type of Device: SOFTWARE FOR DIAGNOSIS/TREATMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15236899
• MDR Text Key: 298006134
• Report Number: 1020279-2022-03670
• Device Sequence Number: 1
• Product Code: OSN
• UDI-Device Identifier: 00885556746370
• UDI-Public: 885556746370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71075401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention