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

Catalog Number 71692801

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

It was reported that during surgery sureshot device didn't worked, surgeon free handed procedure.Delay from (0 - 30) minutes reported.No backup device available.No injury or impact to patient reported.

Manufacturer Narrative

The associated sureshot targeter was returned and evaluated.A visual inspection of the device noted small cuts on the cord.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit which could not confirm the stated failure.The sureshot targeter has been recognized by the unit.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The device was manufactured in 2015, which suggests it has been in use for some time.The sureshot targeter is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.A second generation targeter has been released and is available for use.Please reference device 71692851 when replenishing.No additional actions are being taken at this time; however smith and nephew will continue to monitor for future complaints and investigate further as necessary.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: 8468286
• MDR Text Key: 140433557
• Report Number: 1020279-2019-01298
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

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: ND3896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1