MAUDE Adverse Event Report: ORTHOFIX SRL GBEAM; K-WIRE

Model Number	99-187287
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that the k-wire torqued at the notch causing the wire to break during the subtalar fusion.The shorter end up to the notch of the guide wire is still located interior of the calcaneus in the patient.The patient is stable and the remainder of the device was discarded.

• Brand Name: GBEAM
• Common Device Name: K-WIRE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; 37012 bussolengo (vr); 37012 ; IT 37012
• MDR Report Key: 9475475
• Report Number: 2183449-2019-00009
• Device Sequence Number: 19506986
• Product Code: LXH
• UDI-Device Identifier: 18053504360766
• UDI-Public: 18053504360766
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2019
• Report Date (Section F): 12/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: 99-187287
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 95