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

Model Number 99-187287

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 08/20/1961

Event Type  Injury  

Event 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
• Type of Device: GUIDEWIRE,9MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 10543979
• MDR Text Key: 208733346
• Report Number: 2183449-2020-00005
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 18053504360766
• UDI-Public: 18053504360766
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• 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: 59 YR