MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TT CURVED, INSERTER

Model Number	4200-1040
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record was performed for the subject device.The review revealed there were no anomalies or non-conformances generated during manufacture of the subject device that would contribute to this failure condition.The endoskeleton® tt implant curved, inserter's (p/n 4200-1040, lot y140602) tip was broken off and stuck inside of the endoskeleton® tt implant, large, 8mm (p/n 4114-3008, lot a150405).The instrument was used in a manor not intended as it was used past the midline against the warning or technique.The endoskeleton® tt surgical technique was reviewed and states "detach the holder once the trailing edge is inside the disc space.Pivot the implant into its final position using the curved pusher.Note: attempting to pivot the implant with the implant holder may damage the instrument." the endoskeleton® tt implant curved, inserter was used to position the implant in the disc space further than intended.This caused force greater than intended to be exerted on the inserter leading to the inserter's tip failure.
Event or Problem Description
Implanting the tt implant with a tt curved implant holder, the surgeon was just pushing with hand (not hammer) and in the moment of the placement in the disc, the angled implant inserter broke.The inner part in one side and the other part and the implant in other side.The implant was able to be retrieved from the disc space by holding the small extreme of the inner part that remained.The procedure was finished using another tt implant and the tt straight implant inserter.The surgery time did not suffer a big delay and the patient is ok.
Event or Problem Description
Implanting the tt implant with a tt curved implant holder, the surgeon was just pushing with hand (not hammer) and in the moment of the placement in the disc, the angled implant inserter broke.The inner part in one side and the other part and the implant in other side.The implant was able to be retrieved from the disc space by holding the small extreme of the inner part that remained.The procedure was finished using another tt implant and the tt straight implant inserter.The surgery time did not suffer a big delay and the patient is ok.
Additional Manufacturer Narrative
A review of the device history record was performed for the subject device.The review revealed there were no anomalies or non-conformances generated during manufacture of the subject device that would contribute to this failure condition.The endoskeleton tt implant curved inserter (p/n 4200-1040 lot # y140602) tip was broken off and stuck inside of the endoskeleton tt implant, large 8mm (p/n 4114-3008 lot # a150405).Cause unknown.Action limit likely exceeded.

• Brand Name: ENDOSKELETON® TT CURVED, INSERTER
• Common Device Name: CURVED, INSERTER
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 5797048
• Report Number: 3006340236-2016-00004
• Device Sequence Number: 16310869
• Product Code: LXH
• UDI-Device Identifier: M682420010400
• UDI-Public: +M682420010400/$Y1406021
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K083741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: 4200-1040
• Device Catalogue Number: 4200-1040
• Device Lot Number: Y140602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2016
• Supplement Date Received by Manufacturer: 06/17/2016
• Initial Report FDA Received Date: 07/14/2016
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1