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

Catalog Number 71692801

Device Problems Computer Operating System Problem (2898); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/23/2018

Event Type  Injury  

Event Description

It was reported that during surgery the sureshot targeter was not functioning as designed and it was unfit for use. Surgeon had to freehand distal locking to complete the surgery.

Manufacturer Narrative

The associated sureshot targeter was returned and evaluated.  visual inspection of the product found the cord is sliced in one location. A functional evaluation 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.  a clinical evaluation noted that no patient harm or injury occurred as a result of the device related incident. The procedure was completed without surgical delay using freehand distal locking. No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.  when having complications with a sureshot device, we encourage you to refer to user manual for trouble shooting suggestions. 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7631921
• MDR Text Key: 112132064
• Report Number: 1020279-2018-01180
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 71692801
• Device Lot Number: ND1988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/22/2018 Patient Sequence Number: 1