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	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was not returned for evaluation.This instrument is labeled to not be used for final locking.However, the surgeon choose to use this instrument to final lock the set screw.It was during this process that the tip sheared off and became imbedded into the set screw drive pocket.According to the surgeon the broken tip had no affect on the patient.
Event or Problem Description
During the final locking of the set screw on a posterior spinal fusion surgery the tip of the screw driver broke off into the head of the set screw and was left in the patient.

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW DRIVER
• Common Device Name: PEDICLE SCREW DRIVER
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 7437765
• Report Number: 1833824-2018-00007
• Device Sequence Number: 11141331
• Product Code: NKB
• UDI-Device Identifier: 00846468050672
• UDI-Public: (01)00846468050672(10)175199
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/17/2018

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: 175199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR