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

Catalog Number 71692801

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/03/2018

Event Type  malfunction  

Event Description

In the second affiliated hospital of (b)(6) medical university, during the humeral internal nail fixation of closed reduction of humeral shaft fracture surgery, the sureshot showed "targeted invalid or broken tool, please exchange!" and it could not be used. Surgery was completed by free hands to insert the distal screws under x-rays.

Manufacturer Narrative

The associated sureshot targeter was returned and evaluated. Visual inspection of the product found a cut on the cord. Our investigation has 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. No additional actions are being taken at this time. 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. Credit will be issued for the device.

• 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: 7807540
• Report Number: 1020279-2018-01611
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 71692801
• Device Lot Number: ND4100
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/03/2018

Is This a Reprocessed and Reused Single-Use Device?

• Patient Age: 36 YR
• Patient Weight: 65
• Patient Outcome(s): Other