MAUDE Adverse Event Report: SMITH NEPHEW, INC. CORI HANDPIECE AND CORI REAL INTELLIGENCE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number REAL INTELLIGENCE # 000031 HANDPIECE # 500184

Device Problem Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

Attachment would not release from cori handpiece.Console error message.During shutdown of cori console, the electronic message is sent to disengage the attachment from the handpiece.This failed.Handpiece sent to smith and nephew for repair.

• Brand Name: CORI HANDPIECE AND CORI REAL INTELLIGENCE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 12827666
• MDR Text Key: 280885401
• Report Number: 12827666
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REAL INTELLIGENCE # 000031 HANDPIECE # 500184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2021
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Female