MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON TL THREADED INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	7200-1004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 22-feb-2018 as regulatory report # 3006340236-2017-00020 ¿ 1 with "follow-up" marked in section g7.Per request, it is being resubmitted as an initial report.A review of the dhr was performed for the subject device.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 device passed inspection and was approved for use.A review of the endoskeleton tl surgical technique guide was performed.The technique warns of trying to pivot or adjust the position of the implant with the implant inserter within the disc space because it may damage the instrument.Multiple inserters are provided within the tl instrument set to ensure the surgeon will have an inserter to place an implant in the event of malfunction.The event reports that the incident occurred during a lateral fusion at disc level l4/5.L4/5 is considered an extreme disc level for lateral access and hence should utilize the angled instrument set.The angled driver is intended for use in the situation in which the inserter failed.The product was returned; it was found that the tab was broken off and the inner shaft was bent resulting in interference with rotation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the attending physician had an incident with an endoskeleton tl threaded inserter as one of the tabs that's used to stabilize the trial seemed to have signs of being worn and broke off when removing the trial from the inserter after the case was finished.The malfunction was discovered after the case when the trial was being removed from the inserter.The planned xlif 4-5 procedure was able to be completed and there were no adverse effects to the patient.

• Brand Name: ENDOSKELETON TL THREADED INSERTER
• 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: 7289333
• Report Number: 3006340236-2017-00020
• Device Sequence Number: 14057463
• Product Code: LXH
• UDI-Device Identifier: 00191375009269
• UDI-Public: 00191375009269
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K140055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 7200-1004
• Device Catalogue Number: 7200-1004
• Device Lot Number: N141113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 02/22/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2014
• 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