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

Catalog Number 71692801

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

It was reported that during surgery, after connecting the controller, device could not be used and displayed the following message: sureshot targeter invalid or broken tool please exchange.Delay of 30 minutes reported.Procedure was completed with a c-arm fluoroscopy, to blind lock the distal end.No patient impact or injury due to this issue.

Manufacturer Narrative

Additional information : device identification.The associated sureshot targeter was returned and evaluated.A visual inspection of the returned device noted the targeter is worn and showed signs of significant use.The cable is squeezed here and there and bandage is placed in different areas on the cord.The device was manufactured in 2016, which suggests it has been in use for some time.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit.An error message was displayed which read, ¿sureshot targeter invalid or broken tool - please exchange.¿ thus, the stated failure was confirmed.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.Damage from repeated use can occur and some causes for the malfunction would include a broken cable, damaged connector, broken from connection, and/or silicone overmolding failure.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.

• 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: 8787757
• MDR Text Key: 150964072
• Report Number: 1020279-2019-02680
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• 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: ND4432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1