MAUDE Adverse Event Report: RTI SURGICAL SLIMFUSE; TRI-LOBE FINAL DRIVER

Model Number	21-FINALDRIV-TL
Medical Device Problem Codes	Break (1069); Fracture (1260)
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 3 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.The surgeon made several attempts to remove the screws and broke multiple devices.All pieces were retrieved and there was a surgical delay of 40 minutes and no patient effect.

• Brand Name: SLIMFUSE
• Common Device Name: TRI-LOBE FINAL DRIVER
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 7541557
• Report Number: 1833824-2018-00014
• Device Sequence Number: 19436101
• Product Code: KWQ
• UDI-Device Identifier: 00846468025793
• UDI-Public: (01)00846468025793(10)119476
• 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-FINALDRIV-TL
• Device Catalogue Number: 21-FINALDRIV-TL
• Device Lot Number: 119476
• 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