MAUDE Adverse Event Report: ORTHOFIX INC. FIREBIRD SFS; ROD GRIPPER

Model Number	51-1480
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that the screw broke off of the rod gripper during the case.No adverse effects to the patient.No delay in the duration of the case.

• Brand Name: FIREBIRD SFS
• Common Device Name: ROD GRIPPER
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6545853
• Report Number: 2183449-2017-00014
• Device Sequence Number: 746035
• Product Code: LXH
• UDI-Device Identifier: 18257200045600
• UDI-Public: 18257200045600
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K994217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2017

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: 51-1480
• Device Lot Number: 30256-MF30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR