MAUDE Adverse Event Report: ORTHOFIX SRL OSCAR; GENERATOR CASEFRAME NON-OPTICAL

Model Number OE3000B/1

Device Problem Intermittent Continuity (1121)

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

Event Date 09/25/2018

Event Type  malfunction  

Event Description

Information provided states that during a case the pierce/probe would not tune to frequency.During the removal of the cement the generator would work only intermittently.The case was completed successfully using the generator.This resulted in a delay in the surgery.

• Brand Name: OSCAR
• Type of Device: GENERATOR CASEFRAME NON-OPTICAL
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 8026632
• MDR Text Key: 125767057
• Report Number: 2183449-2018-00032
• Device Sequence Number: 1
• Product Code: LZV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OE3000B/1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR