MAUDE Adverse Event Report: ORTHOFIX INC PILLAR SA IMPLANT INSERTER

Model Number	51-1480
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Initial information provided states that it was noticed during inventory inspection that the screw was missing from the rod gripper.Additional information was provided stating that the rod gripper was used during a case and the missing screw was noticed after the case.The screw was not returned with the device for evaluation.The location of the missing screw is unknown.

• Brand Name: PILLAR SA IMPLANT INSERTER
• Common Device Name: IMPLANT INSERTER
• Manufacturer (Section D): ORTHOFIX INC; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6480572
• Report Number: 2183449-2017-00012
• Device Sequence Number: 1289375
• Product Code: LXH
• UDI-Device Identifier: 18257200045600
• UDI-Public: 18257200045600
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 51-1480
• Device Lot Number: 41590-PH15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 04/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR