MAUDE Adverse Event Report: RTI SURGICAL SLIMFUSE; DRIVER

Model Number	21-DRIVER-TF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history review was done and the device met all specifications.This is report 1 of 5.Several attempts have been made to get the device back for inspections and it still has not been returned.
Event or Problem Description
During a slimfuse removal case the set screws stripped and when the doctor tried to remove the screws he broke multiple devices in the process.There was a 40 minute surgical delay while the surgeon made multiple attempts to remove the screws with different devices.There was no patient effect.

• Brand Name: SLIMFUSE
• Common Device Name: DRIVER
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette 49855
• MDR Report Key: 7541588
• Report Number: 1833824-2018-00012
• Device Sequence Number: 2512263
• Product Code: KWQ
• UDI-Device Identifier: 00846468025700
• UDI-Public: (01)00846468025700(10)275742
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K072703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 21-DRIVER-TF
• Device Catalogue Number: SAME
• Device Lot Number: 275742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1