MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT TARGETER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 71692801

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the sureshot targeter didn't display dynamic imaging after connected to the monitor.There was not a back-up device available and the c- arm was utilized to complete the surgery. the procedure was delay for less than 30 minutes.It is unknown if there was a patient impact or injury due to this issue.

Manufacturer Narrative

The associated sureshot targeter was returned and evaluated.A visual inspection of the device noted no obvious damage.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit which could not confirm the stated failure.However, although our investigation could not confirm the stated failure, this failure mode has been previously identified and the device is currently being redesigned to help reduce/eliminate this issue from recurrence.No additional actions are being taken at this time.However we will continue to monitor for future complaints and investigate further as necessary.When having complications with a sureshot device, we encourage you to refer to user manual for trouble shooting suggestions.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: SURESHOT TARGETER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348110
• MDR Text Key: 136502406
• Report Number: 1020279-2019-00623
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K092497
• 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: 05/08/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71692801
• Device Lot Number: ND4168
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1