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

Catalog Number 71692801

Device Problem Calibration Problem (2890)

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

Event Date 08/15/2019

Event Type  malfunction  

Event Description

It was reported that during use, it was found that navigation is not accurate, the disc has a large error after calibration.Delay of less than 30 minutes.Procedure was concluded with the same device but screws were inserted free hand.

Manufacturer Narrative

It was reported that during use, it was found that navigation is not accurate, the disc has error after calibration.The associated sureshot targeter was returned and evaluated.Visual inspection of the returned product found blemishes on the rubber.A 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 and the stated failure could not be confirmed.The device was recognized by the unit.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 (b)(4) when replenishing.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 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: 9008378
• MDR Text Key: 158171379
• Report Number: 1020279-2019-03332
• 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
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• 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: 09/09/2019
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1