MAUDE Adverse Event Report: ORTHOFIX INC SPINAL FIXATION SYSTEM TORQUE HANDLE; TORQUE T-HANDLE

Model Number	55-1068
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during the case the surgeon turned the torque t-handle clockwise to tighten the set screw.At that time the torque broke and fell apart resulting in a delay in the case.There were no adverse effects to the patient.

• Brand Name: SPINAL FIXATION SYSTEM TORQUE HANDLE
• Common Device Name: TORQUE T-HANDLE
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6312990
• Report Number: 2183449-2017-00006
• Device Sequence Number: 768971
• Product Code: LXH
• UDI-Device Identifier: 18257200053926
• UDI-Public: 18257200053926
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 55-1068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1