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

Catalog Number	5210-1005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2015
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.The tip of the subject device sheared off of the instrument during the surgical procedure.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.The 510(k) k151596 was submitted and approved to change the hexalobular size to a no 8.
Event or Problem Description
The surgeon was performing a cervical fusion procedure at c6-c7.The surgeon followed the correct procedure by utilizing the punch awl before placing the screw.The punch awl angle trajectory and depth was analyzed under fluoro.A tcs swivel hex driver was used to insert a 3.5mm x 14mm locking screw into c6.During final x-ray, the cage and two screw construct were identified as being placed too off midline to the patient anatomy.The surgeon went to remove the screw in c6; however, the surgeon could not re-engage the hex driver into the screw head.Under the microscope, the surgeon identified the distal tip of the hex driver had partially broken off into the screw head.The implant was removed by the surgeon burring the bone of the c6 vertebrae directly above the screw hole.The removal of bone anterior to the screw allowed the surgeon to remove the implant device with the screw still engaged.The procedure was finished using another cervical standalone system.No adverse effects or injury to the patient as a result of the malfunction.

• Brand Name: ENDOSKELETON® TCS NO 6 SWIVEL DRIVER
• Common Device Name: HEX DRIVER
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5397347
• Report Number: 3006340236-2015-00018
• Device Sequence Number: 997449
• Product Code: HXX
• UDI-Device Identifier: M682521010050
• UDI-Public: +M682521010050/$G150101O
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Report Date (Section B): 01/27/2016

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 Catalogue Number: 5210-1005
• Device Lot Number: G150101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2015
• 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