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 11/05/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the sureshot displayed a message that indicated that the target was broken or non-valid.10 minutes delay.No patient injuries.The surgeon change to old method of using x ray.

Manufacturer Narrative

It was reported that during surgery the sureshot displayed a message that indicated that the targeter was broken or non-valid.The associated device, used in treatment, was returned for evaluation.Visual inspection of the returned product found no obvious signs of damage.However, the device shows signs of wear.A functional evaluation was performed and the examination of the prom board indicated the srom wire is defective.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.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A relationship between the device and the reported incident could be corroborated.The device was manufactured in 2017.The targeter is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Damage from repeated use can occur and probable 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.Based on this investigation, the corrective action has been implemented.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.

• 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: 9396148
• MDR Text Key: 168645851
• Report Number: 1020279-2019-04228
• 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: 02/06/2020

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: 12/21/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 55