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

Catalog Number 71692801

Device Problem Output Problem (3005)

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

Event Date 07/14/2019

Event Type  malfunction  

Event Description

It was reported that while connecting the jack of the sureshot, the following message appears: "targeter not found".No back-up available and no delay reported.No patient injury or impact involved.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there was a s&n backup available during surgery and no alternative technique was required to finish the surgery, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Manufacturer Narrative

The associated sureshot targeter was not returned for evaluation.Therefore a product analysis could not be performed and the stated failure could not be confirmed.The device was manufactured in 2015, which suggests it has been in use for some time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The sureshot targeter is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.The sureshot device user manual is available, identifying pre-operative requirements for use and troubleshooting suggestions if needed.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.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: 8920320
• MDR Text Key: 155185428
• Report Number: 1020279-2019-03119
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2019

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
• Device Lot Number: ND3915
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 12/20/2019
• Supplement Dates FDA Received: 10/07/2019; 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1