MAUDE Adverse Event Report: ORTHOFIX SRL G-BEAM; GUIDEWIRE,9MM

Model Number	99-187287
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/1961
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on information provided by representative, two guidewire tip dislocated from the guidewire and remain in the calcaneus of the lateral column of the patient.The tips dislocated as the surgeon made several attempts to obtain the correct angle for the wire.

• Brand Name: G-BEAM
• Common Device Name: GUIDEWIRE,9MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 10543979
• Report Number: 2183449-2020-00005
• Device Sequence Number: 19669193
• Product Code: LXH
• UDI-Device Identifier: 18053504360766
• UDI-Public: 18053504360766
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: 99-187287
• Device Catalogue Number: 99-187287
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/20/2020
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2020
• 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: 59 YR