MAUDE Adverse Event Report: ORTHOFIX SRL G-BEAM; K-WIRE

Model Number	99-187288
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that during a plantalar fusion with g-beam case the tip of the kirschner wire (k-wire) broke.The surgeon continued with the procedure and left the broken k-wire tip in the patient.

• Brand Name: G-BEAM
• Common Device Name: K-WIRE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 8183190
• Report Number: 2183449-2018-00037
• Device Sequence Number: 1459911
• Product Code: LXH
• UDI-Device Identifier: 18053504360773
• UDI-Public: 18053504360773
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/19/2018
• Report Date (Section F): 12/19/2018

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: 99-187288
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2018
• 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: 66 YR
• Patient Weight: 91