MAUDE Adverse Event Report: ORTHOFIX INC. PILLAR SA PTC; PILLAR SA DRILL BIT

Model Number	49-1109
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information provided states that during an l5-s1 anterior fusion case the tip broke off of the drill bit.The surgeon determined that the tip was securely imbedded in the bone and did not pose a risk of migration.A 5 mm portion of the drill bit remains in patients' l5 vertebra.

• Brand Name: PILLAR SA PTC
• Common Device Name: PILLAR SA DRILL BIT
• Manufacturer (Section D): ORTHOFIX INC.; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 7329950
• Report Number: 2183449-2018-00004
• Device Sequence Number: 111555
• Product Code: DZJ
• UDI-Device Identifier: 18257200044108
• UDI-Public: 18257200044108
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161129
• 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): 03/09/2018

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: 49-1109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 107