MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TCS STRAIGHT NO 6 HEX DRIVER

Catalog Number	5210-1004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a retrospective medical device report for a complaint on the subject device.It was determined this complaint required a medical device report after a review of medical device report determination procedures.Patient information is not available for this report.A review of the device history records was performed for the subject device.The review revealed there were no anomalies or discrepancies were noted within the device history records for the product of the subject device lot.All records showed product met specifications and passed the incoming inspection.The subject device is an instrument and is not implanted or explanted.The tip of the subject device sheared off of the instrument during the surgical procedure as the subject device was attempting to engage and seat the tcs bone screw.A recall was initiated in february 2015 to return and quarantine subject instrument lot.Through capa investigations, it was determined the no 6 hexalobular driver design was deficient.510(k) (b)(4) was submitted and approved to change the hexalobular size to a no 8.
Event or Problem Description
The driver tip sheared off inside the screw head at the point of contact with the hex drive feature.The tip of the driver was removed from the screw using a needle nose pliers.Procedure was completed with no injury or adverse effect to the patient as a result of the malfunction.

• Brand Name: ENDOSKELETON® TCS STRAIGHT NO 6 HEX DRIVER
• Common Device Name: HEX DRIVER
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5397013
• Report Number: 3006340236-2015-00014
• Device Sequence Number: 10787930
• Product Code: HXX
• UDI-Device Identifier: M682521010040
• UDI-Public: +M682521010040/$G150101N
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Report Date (Section B): 01/25/2016

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: Health Professional
• Device Catalogue Number: 5210-1004
• Device Lot Number: G150101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2015
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9099519-02/18/2015-001-R
• Patient Sequence Number: 1