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

Model Number 71692801

Device Problem Break (1069)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/04/2020

Event Type  Injury  

Event Description

It was reported that the connector had a broken part and was not able to connect to the interface.The surgery was completed using a radiolucent drill.A 10 minutes delay reported.No patient injuries reported.An s&n backup was available.

Manufacturer Narrative

Results of investigation: it was reported that the connector had a broken part and was not able to connect to the interface.The surgery was completed using a radiolucent drill.The associated sureshot targeter, intended for use in treatment, was returned and evaluated.Visual inspection of the returned product found damaged connector.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 which confirmed the stated failure.An error message was showing on the screen.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.The device was manufactured in 2017.This 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.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.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.

Manufacturer Narrative

It was reported that the connector had a broken part and was not able to connect to the interface.The surgery was completed using a radiolucent drill.The associated sureshot targeter, intended for use in treatment, was returned and evaluated.Visual inspection of the returned product found damaged connector.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 which confirmed the stated failure.An error message was showing on the screen.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.The device was manufactured in 2017.This 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.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.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 the information provided no further medical assessment is warranted.No additional actions are being taken at this time; however we 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 rd.; memphis TN 38116
• MDR Report Key: 10618836
• MDR Text Key: 209540575
• Report Number: 1020279-2020-05083
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 03596010648167
• UDI-Public: 03596010648167
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71692801
• Device Catalogue Number: 71692801
• Device Lot Number: ND5041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 10/23/2020
• Supplement Dates FDA Received: 10/21/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention