MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. PAK NEEDLE - TROCAR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	PK1002
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the distal tip of the cannula broke off inside the vertebral body of the patient.The surgeon attempted to remove the tip, but it was determined this would cause more harm than leaving the tip in place.It was disclosed to the patient that there was a purposefully retained foreign body.No further complications arose from the procedure, and it was completed as planned.The broken trocar was saved, images were captured, and it will be returned to the manufacturer for failure analysis.Manufacturer response for trocar, pak needle - trocar (per site reporter).We have requested to return the device for failure analysis.Further response from the manufacturer will be shared with medsun.

• Brand Name: PAK NEEDLE - TROCAR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 7989983
• Report Number: 7989983
• Device Sequence Number: 19225485
• Product Code: LXH
• UDI-Device Identifier: 00853508002225
• UDI-Public: (01)00853508002225
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2018
• Report Date (Section F): 10/11/2018

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: Health Professional
• Device Catalogue Number: PK1002
• Device Lot Number: BE3658
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 85
• Date Report Sent to FDA: 10/11/2018