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

Catalog Number 71692801

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  malfunction  

Event Description

It was reported that the sureshot targeter couldn't be used, and the computer screen showed an error.The surgeon free handed the insertion of the distal screws.There was no patient injury reported.

Manufacturer Narrative

The associated sureshot targeter was returned and evaluated.Visual inspection of the product found no obvious damage.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation has confirmed 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.When having complications with a sureshot device, we encourage you to refer to user manual for trouble shooting suggestions.No additional actions are being taken at this time.However we will continue to monitor for future complaints and investigate further as necessary.

Manufacturer Narrative

The associated sureshot targeter was returned and evaluated.Visual inspection of the product found no obvious damage.A serial number was provided and the review of the manufacturing records for the listed serial number did not reveal any deviation from the standard manufacturing processes.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 targeter is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Damage from repeated use can occur and some causes for the malfunction would include a broken cable, damaged connector, broken srom connection, and/or silicone overmolding failure.Our investigation found that the subject device has been previously evaluated for similar events and an upgrade to the targeter has taken place.A second generation targeter has been released and is available (please reference device 71692851) for use.The sureshot 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 we 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.Credit has been issued for the device.

• Brand Name: SURESHOT TARGETER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 7931830
• MDR Text Key: 122626477
• Report Number: 1020279-2018-02076
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• 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: ND3874
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1