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

Catalog Number 71075401

Device Problem Failure to Read Input Signal (1581)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 07/28/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, at the moment of trying to import an x-ray ((b)(4)) into the smart tsf software, and have the software detect the beacon on the lateral view, the software did not recognized the image.It was cropped the anterior part of the image away ((b)(4)), and it was able to get the software to find the beacon in the smart tsf account.Unfortunately, this image did not work for the physician.Surgeon complained about wasted time (3hr) in clinic, and unwanted radiation exposure to the patient.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the patient was not under anesthesia while the surgeon unsuccessfully attempted to import the x-ray image to the tsf software (failure to recognize the beacon) as it was originally thought; therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.

• 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: 15241956
• MDR Text Key: 305353555
• Report Number: 1020279-2022-03690
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71075401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1