MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TAS; 6.5MM DIA, BONE SCREW, 30MM

Catalog Number	2300-6530
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the subject device.The review revealed there were no anomalies or non-conformances generated during the manufacture of the subject device that would contribute to this complaint condition.Endoskeleton® tas bone screws are designed to be inserted at a natural angle (45°) through the implant and into the bone.As it was reported the bone screw was being installed at a difficult angle, it is plausible that the tas bone screw was not implanted at a natural angle and contributed to the failure of the bone screw.Neither the subject device nor applicable imaging films were returned to the manufacturer for evaluation; therefore, no further investigation could be performed and the cause of the event cannot be determined.Device not returned to manufacturer.
Event or Problem Description
Endoskeleton tas 6.5mm dia, bone screw, 30mm has broken during a l5-s1 alif procedure with screws.The surgeon was trying to get the screw through the implant at a very difficult angle when the bone screw broke.The surgeon was using a tas screwdriver that was included in the set to when attempting to install the bone screw.The broken bone screw was removed per the surgical technique and then discarded by the hospital.There were no adverse effect to the patient as a result of this bone screw failure.

• Brand Name: ENDOSKELETON® TAS
• Common Device Name: 6.5MM DIA, BONE SCREW, 30MM
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5866928
• Report Number: 3006340236-2016-00006
• Device Sequence Number: 403688
• Product Code: OVD
• UDI-Device Identifier: M682230065300
• UDI-Public: +M682230065300/$V13/16D20160101P
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2016

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: 2300-6530
• Device Lot Number: V13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2016
• Initial Report FDA Received Date: 08/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1