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

Catalog Number	71075401
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1020279-2022-03690
• Device Sequence Number: 4693214
• Product Code: OSN
• UDI-Device Identifier: 00885556746370
• UDI-Public: 885556746370
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71075401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown