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

Model Number	05-SIMPLEDRIVER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was returned and inspected.Hardness inspection passed specifications and the dhr review determined that the instrument was manufactured to specifications.Since the instrument tip was not returned a complete investigation could not be completed.
Event or Problem Description
While tightening a screw during a posterior spinal fusion surgery the tip of the screw driver broke off and was not able to be removed from the head of the screw.The surgery was completed successfully with no injury to the patient.

• Brand Name: RTI SURGICAL STREAMLINE MIS, SCREW INSERTER
• 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: 7494117
• Report Number: 1833824-2018-00010
• Device Sequence Number: 1339987
• Product Code: NKB
• UDI-Device Identifier: 00846468050696
• UDI-Public: (01)00846468050696(10)280819
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2018

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: 05-SIMPLEDRIVER
• Device Catalogue Number: SAME
• Device Lot Number: 280819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1