MAUDE Adverse Event Report: ORTHOFIX INC. FIREBIRD SYSTEM; MODULAR SCREW DRIVER

Model Number	52-1832 (4)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during a case the drivers would not tighten onto the screws.This resulted in a delay in the case.The surgeon placed the heads on the screws and used a different driver to complete the case.There were no adverse effects to patient.

• Brand Name: FIREBIRD SYSTEM
• Common Device Name: MODULAR SCREW DRIVER
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 7405212
• Report Number: 2183449-2018-00008
• Device Sequence Number: 19148517
• Product Code: LXH
• UDI-Device Identifier: 18257200047512
• UDI-Public: 18257200047512
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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
• Operator of Device: Physician
• Device Model Number: 52-1832 (4)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR