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

Model Number	4200-1021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this regulatory report was previously submitted on 22-feb-2018 as regulatory report # 3006340236-2017-00015 ¿ 1 with "follow-up" marked.Per request, it is being resubmitted as an initial report.The surgical technique guide states pivoting the implant with the implant holder may damage the instrument.There is only one tt thin pusher included in the set.The design history file (dhf) was reviewed and there are no new potential risks.The ncr identified the potential cause is related to excessive insertion force.There were no adverse effects to the patient.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Per the sales representative, on (b)(6) 2017 the surgeon was using the thin pusher to position the implant during a tlif and the thin pusher broke.Per the sales representative, the surgeon was able to remove the broken piece and complete the case.

• 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: 7290586
• Report Number: 3006340236-2017-00015
• Device Sequence Number: 2496889
• Product Code: LXH
• UDI-Device Identifier: 00191375003014
• UDI-Public: 00191375003014
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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): 04/06/2020

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: 4200-1021
• Device Catalogue Number: 4200-1021
• Device Lot Number: UU161103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• 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: 11/01/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown