MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY CEQUENCE FIXED HANDLE SCREW DRIVER

Model Number	0259-1001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the second of two reports that were filed for the same patient and the same surgery.Two drivers broke during this surgery and both tips of the drivers were not able to be retrieved and thus were left in the patient.These drivers, without the tips, were inspected by pioneer surgical technology and the hardness values were within specifications.The dhrs were also reviewed and all conformed to specifications.The surgeon has no plans to revise.
Event or Problem Description
During a anterior cervical procedure there were two screw driver tips that broke off and were not able to be removed from the patient.There was no reported injury cause to the patient from these drivers breaking.This report is the second of two reports on these two drivers.

• Brand Name: PIONEER SURGICAL TECHNOLOGY CEQUENCE FIXED HANDLE 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: 6562039
• Report Number: 1833824-2017-00016
• Device Sequence Number: 13607190
• Product Code: KWQ
• UDI-Device Identifier: 00846468018542
• UDI-Public: (01)00846468018542(10)1001
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082821
• 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): 05/11/2017

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: 0259-1001
• Device Catalogue Number: SAME
• Device Lot Number: 1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1