MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TCS; 3.5MM DIA, LOCKING BONE SCREW, 16MM

Model Number 5302-3516

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

One of the returned bone screws had the locking collar separated from the bone screw.The other bone screw was returned as it was implanted and then explanted.A review of the products' device history record was performed for subject devices.The review revealed there were no anomalies or non-conformances generated during the manufacture of these devices that would contribute to this complaint condition.The devices passed inspection and were approved for initial use.Endoskeleton® tcs surgical technique guide (60-0021 rev 04) was reviewed.Surgical technique states "create pilot holes for the screws using the appropriate length awl (relative to anticipated screw length usage) under a/p and lateral fluoroscopy." "the awl guide must be used to help facilitate the desired pilot hole trajectory and position.Confirm desired awl trajectory prior to awl advancement using fluoroscopy." it was reported that fluoroscopy was not used to confirm the trajectory of the pilot hole prior to inserting the bone screws.Thus, the surgeon did not follow titan spine's surgical procedure.Endoskeleton® tcs locking bone screws that are not inserted at the proper trajectory have the potential to have the locking collar contact the cage of the implant.This contact can cause the locking collar to bend to a diameter greater than the bone screw.As a result, the locking collar would fall off the bone screw.A proper and unimpeded trajectory should be utilized for proper seating of tcs locking bone screws.The information presented about this incident, the pilot hole was created at an improper trajectory.The surgeon did not follow the surgical technique to ensure the trajectory of the pilot hole prior to inserting the bone screw.The bone screw was then being inserted at an improper trajectory which resulted with the locking collar falling off of the bone screw.

Event Description

Two (2) screws were used and 1 screw broke.Another screw went in and out and the surgeon did not want to re-use it after unlocking it for fear it would break again.The surgeon used the drill guide and the screw broke as he was locking it in place.Both pieces were removed from the patient and the case went on.Fluoroscopy did not confirm the drill trajectory before the screw was inserted.Hand held poly axil drill from the set was used.The straight driver (p/n: 5210-1004) was being use at the time.The screw was inserted nearly all the way when it broke off.The screw broke before we got to the point of using fluoroscopy again to check its trajectory.

Event Description

2 screws were used and 1 screw broke.Another screw went in and out and the surgeon did not want to re-use it after unlocking it for fear it would break again.The surgeon used the drill guide and the screw broke as he was locking it in place.Both pieces were removed from the patient and the case went on.Fluoroscopy did not confirm the drill trajectory before the screw was inserted.Hand held poly axil drill from the set was used.The straight driver (p/n: 5210-1004) was being use at the time.The screw was inserted nearly all the way when it broke off.The screw broke before we got to the point of using fluoroscopy again to check its trajectory.

Manufacturer Narrative

One of the returned bone screws had the locking collar separated from the bone screw.The other bone screw was returned as it was implanted and then explanted.A review of the products' device history record was performed for subject devices.The review revealed there were no anomalies or non-conformances generated during the manufacture of these devices that would contribute to this complaint condition.The devices passed inspection and were approved for initial use.Endoskeleton® tcs surgical technique guide (60-0021 rev 04) was reviewed.Surgical technique states "create pilot holes for the screws using the appropriate length awl (relative to anticipated screw length usage) under a/p and lateral fluoroscopy." "the awl guide must be used to help facilitate the desired pilot hole trajectory and position.Confirm desired awl trajectory prior to awl advancement using fluoroscopy." it was reported that fluoroscopy was not used to confirm the trajectory of the pilot hole prior to inserting the bone screws.Thus, the surgeon did not follow titan spine's surgical procedure.Endoskeleton® tcs locking bone screws that are not inserted at the proper trajectory have the potential to have the locking collar contact the cage of the implant.This contact can cause the locking collar to bend to a diameter greater than the bone screw.As a result, the locking collar would fall off the bone screw.A proper and unimpeded trajectory should be utilized for proper seating of tcs locking bone screws.The information presented about this incident, the pilot hole was created at an improper trajectory.The surgeon did not follow the surgical technique to ensure the trajectory of the pilot hole prior to inserting the bone screw.The bone screw was then being inserted at an improper trajectory which resulted with the locking collar falling off of the bone screw.

• Brand Name: ENDOSKELETON® TCS
• Type of Device: 3.5MM DIA, LOCKING BONE SCREW, 16MM
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6362786
• MDR Text Key: 68762010
• Report Number: 3006340236-2017-00003
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: M682530235160
• UDI-Public: +M682530235160/$V11/16D20151001S
• Combination Product (y/n): N
• PMA/PMN Number: K142940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5302-3516
• Device Catalogue Number: 5302-3516
• Device Lot Number: V11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1