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 04/26/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the product damaged and doesn't work anymore.No backup device was available and a delay greater than 30 minutes was reported.The surgeon finished the procedure free hands.

Manufacturer Narrative

The affected sureshot targeter was returned and evaluated.Visual inspection of the returned targeter found no obvious signs of damage.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit which could not confirm the stated failure.The device functions as intended.The sureshot targeter was recognized by the software.The device was manufactured in 2016, 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.Our investigation found that an upgrade to the targeter has taken place.A second generation targeter has been released and is available for use.Please reference device 71692851 when replenishing.The device user manual is available, identifying pre-operative requirements for use and troubleshooting suggestions if needed.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: 8624645
• MDR Text Key: 145531691
• Report Number: 1020279-2019-01978
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 07/20/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 07/17/2019
• Supplement Dates FDA Received: 07/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1