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

Model Number 71692801

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Connection Problem (2900)

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

Event Date 03/16/2017

Event Type  malfunction  

Event Description

It was reported that the sureshot targeter did not work when connected to the controller.The controller displayed an error message that read "the targeter is broken, please exchange." this failure resulted in 40 minutes surgery delay time.

Manufacturer Narrative

Corrections: manufacturer's code under manufacturer report number has been incorrectly assigned to this report.Correct manufacturer's code is (b)(4) investigation results.Pdf.

• 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: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6420168
• MDR Text Key: 70698190
• Report Number: 1643264-2017-00153
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 71692801
• Device Catalogue Number: 71692801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR
• Patient Weight: 55