MAUDE Adverse Event Report: ORTHOFIX SRL TRUELOK; TL, WIRE

Model Number 54-1215

Device Problem Break (1069)

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

Event Date 10/01/2019

Event Type  Injury  

Event Description

Information provided states that on (b)(6) 2019 the patient had a truelok frame placed on right foot and ankle.The patient returned to clinic approximately 2 weeks after surgery for post op follow-up.It was noticed at that time that a strut and two pins had broken.A revision surgery was performed to replace the pins and strut.All pieces of the pins were successfully removed from the patient.

• Brand Name: TRUELOK
• Type of Device: TL, WIRE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, 37012 ; IT 37012
• MDR Report Key: 9312523
• MDR Text Key: 183428103
• Report Number: 2183449-2019-00008
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 18033509853821
• UDI-Public: 18033509853821
• 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: 10/07/2019,11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 54-1215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2019
• Event Location: Home
• Date Report to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR