MAUDE Adverse Event Report: TITAN SPINE ENDOSKELETON¿ TA INTERBODY SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2106-1003
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis product id: 2106-1003 lotno: y160333 visual and optical inspection revealed the threads on the tip of the holder are damaged.Damage present was likely caused by cross-threading.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a healthcare professional via a manufacturer representative regarding a patient with pre-operative di agnosis for adult deformity.Procedure or technique used was anterior/posterior fusion.Levels implanted 2.It was reported that the probe was bent at the distal tip.Scissor jack assembly broken/bent at the distal end (will no longer open and close).Threads at the distal end of the instrument are stripped.Broaches/rasps and dilators will no longer thread onto the handle.There was no fragment left inside the patient.There was no patient symptoms or complications as a result of this event.

• Brand Name: ENDOSKELETON¿ TA INTERBODY SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer (Section G): TITAN SPINE; 6140 w. executive dr. suite a; mequon WI 53092
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 19150141
• Report Number: 3006340236-2024-00003
• Device Sequence Number: 9420271
• Product Code: LXH
• UDI-Device Identifier: 00191375000433
• UDI-Public: 00191375000433
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: 2106-1003
• Device Catalogue Number: 2106-1003
• Device Lot Number: Y160333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2016
• 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 Age: 74 YR
• Patient Sex: Female