MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS FINAL DRIVER; SCREW 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	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter claimed that there was no injury to the patient caused by this occurrence.The tip remains implanted so therefore was not able to be inspected.The remainder of the screw driver was returned for evaluation and it was found to be within specifications for hardness and visually acceptable except for the screw driver tip being missing.The dhr was reviewed and the records show that this instrument was manufactured to specifications.
Event or Problem Description
During a posterior spinal fusion surgery, the tip of the screw driver broke off in the patient.The tip was unable to be retrieved and remains in the patient.Surgery was completed without incident and there was no reported affect on the patient caused by the implanted screw driver tip.

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS FINAL DRIVER
• Common Device Name: SCREW DRIVER
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 6681719
• Report Number: 1833824-2017-00020
• Device Sequence Number: 13967998
• Product Code: NKB
• UDI-Device Identifier: 00846468050658
• UDI-Public: (01)00846468050658(10)149072
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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: 05-FINALDRIVER
• Device Catalogue Number: SAME
• Device Lot Number: 149072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1