MAUDE Adverse Event Report: ORTHOFIX SRL ANKLE HINDFOOT NAILING SYSTEM; INTRAMEDULLARY NAIL

Model Number 99-T77020

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2018

Event Type  Injury  

Event Description

Information provided states that the titanium ankle hindfoot nail that was implanted on (b)(6) 2017 broke during treatment.The removal of the nail took place on (b)(6) 2018 at which time part of the nail was unable to be retrieved and remains in the patient.

• Brand Name: ANKLE HINDFOOT NAILING SYSTEM
• Type of Device: INTRAMEDULLARY NAIL
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 8094953
• MDR Text Key: 128055020
• Report Number: 2183449-2018-00033
• Device Sequence Number: 1
• Product Code: HSB
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 99-T77020
• Device Lot Number: B1047979
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/05/2018
• Event Location: Home
• Date Report to Manufacturer: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other