MAUDE Adverse Event Report: ORTHOFIX SRL FITBONE; LOCKING SCREW

Model Number	60000365
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that the patient had a fitbone nail implanted in femur on (b)(6) 2020.It was noticed at a post-op follow up that the screw had backed out.The patient underwent a revision surgery on (b)(6) 2020 to replace the screw.Patient is currently doing well.

• Brand Name: FITBONE
• Common Device Name: LOCKING SCREW
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 11012690
• Report Number: 2183449-2020-00009
• Device Sequence Number: 14576965
• Product Code: HSB
• UDI-Device Identifier: 04260170141538
• UDI-Public: 04260170141538
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2020
• Report Date (Section F): 11/13/2020

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: Lay User/Patient
• Device Model Number: 60000365
• Device Catalogue Number: 60000365
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/13/2020
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR