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

Model Number	05-SCREW-INS-THRD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No instruments were returned but were disposed of.The tips remain in the patient and since the surgery was completed successfully the surgeon did not have any concerns.The dhr was reviewed for this lot of instruments and the instruments were manufactured to the defined specifications.
Event or Problem Description
During a spinal surgery, the hex tip portions of two screw drivers broke off in the screw heads and were not able to be removed.The surgery was completed successfully and with no injury to the patient.Since the broken tips were contained within the spinal construct and beneath the locked spinal rod, the surgeon believes that this will have no negative results on the construct or the patient.

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW 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: 7340951
• Report Number: 1833824-2018-00005
• Device Sequence Number: 18871929
• Product Code: NKB
• UDI-Device Identifier: 00846468050672
• UDI-Public: (01)00846468050672(10)231189
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2018

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-SCREW-INS-THRD
• Device Catalogue Number: SAME
• Device Lot Number: 231189
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1