MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	4200-1040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 16-feb-2018 as regulatory report # 3006340236-2017-00014¿1 with "follow-up" marked.Per request, it is being resubmitted as an initial report.The endoskeleton tt design history records were reviewed.There were no non-conformities identified.With the age of the device the issue may have occurred due to normal wear and tear.The endoskeleton tt set configurations were reviewed and there is an additional inserter within the set for use in case of malfunction.The endoskeleton tt surgical technique was reviewed, and the surgical technique 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." this warns the surgeons not to use the inserter as a final positioning instrument.The product was returned and it was found that the tip of the shaft was broken.It was determined that the user did not follow surgical technique properly.In using the inserter to position the cage past mid-line, the user did not follow surgical technique of using the pusher for final positioning.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was a broken endoskeleton tt curved implant inserter.This occurred during a tlif procedure.The sales re presentative stated he did not attend the case because the surgeon was doing the cases without informing the sales representative from gmbh.The sales representative sent the surgeon a second curved implant inserter in case of damage with the original curved implant inserter.The broken tip occurred during insertion in the cage.The surgeon used the new tt curved holder-handle to complete the surgery.There are no known adverse effects to the patient.

• Brand Name: ENDOSKELETON TT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE, LLC; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: jane rodd ; 6140 w. executive dr. suite a; mequon, WI 53092 ; 2622427801
• MDR Report Key: 7278738
• Report Number: 3006340236-2017-00014
• Device Sequence Number: 19442319
• Product Code: LXH
• UDI-Device Identifier: 00191375002994
• UDI-Public: 00191375002994
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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 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: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 02/16/2018
• Supplement Report FDA Received Date: 02/16/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown