MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY MIS FINAL DRIVER; STREAMLINE, MIS, FINAL DRIVER

Model Number	05-FINALDRIVER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and passed all inspection criteria except for the broken tip.Dimensional inspection of the tip was not possible because it remains in the patient.A dhr was reviewed for this device and the instrument was manufactured to the defined specifications.This mdr is associated with mdr 1833824-2018-00038.
Event or Problem Description
It was reported that the final driver tip broke when the surgeon was trying to remove a set screw to retrieve a disassociated pedicle screw.The tip of the driver broke and is implanted in the screw in the patient.Surgery was completed successfully and with no injury to the patient.

• Brand Name: PIONEER SURGICAL TECHNOLOGY MIS FINAL DRIVER
• Common Device Name: STREAMLINE, MIS, FINAL DRIVER
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 8134609
• Report Number: 1833824-2018-00039
• Device Sequence Number: 2080944
• Product Code: NKB
• UDI-Device Identifier: 00846468050658
• UDI-Public: (01)00846468050658(10)299372
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 05-FINALDRIVER
• Device Catalogue Number: SAME
• Device Lot Number: 299372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1