MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE OCT OCCIPITO-CERVICO-THORACIC FINAL DRIVER; SCREW DRIVER

Model Number	26-FNLDRIVER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument was returned but the tip of this instrument remained in the patient and was not returned.The dhr was also reviewed and the device was documented as being manufactured to rti surgical's specifications.Evaluation of this device and the resulting investigation is on-going.
Event or Problem Description
During a posterior occipito-cervico-thoracic fusion surgery, the final set screw driver tip broke off in the set screw.This was not able to be removed and remains in the patient.Surgery was completed successfully.

• Brand Name: RTI SURGICAL STREAMLINE OCT OCCIPITO-CERVICO-THORACIC FINAL DRIVER
• Common Device Name: SCREW DRIVER
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 5484798
• Report Number: 1833824-2016-00013
• Device Sequence Number: 300246
• Product Code: HXX
• UDI-Device Identifier: 00846468029302
• UDI-Public: (01)00846468029302(10)229134
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2016

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: 26-FNLDRIVER
• Device Catalogue Number: SAME
• Device Lot Number: 229134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2016
• Initial Report FDA Received Date: 03/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1