MAUDE Adverse Event Report: STRYKER SPINE-US INSERTER TRITANIUM TL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48930000
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery a tritanium tl inserter would not release the implant at the desired location.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by utilizing another inserter and implant.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records for this lot could not be performed as a valid lot code was not provided and could not be obtained.The device was not returned after 3 attempts to the field and no further information was provided.The surgical technique states that "if there is difficulty with unthreading the tl steerable inserter from the implant, first re-attach the tl steerable inserter driver to the inner shaft and unthread the inner shaft from the implant with this tool.Once disengaged, remove the inserter from the disc space ensuring the black rotation wings are in the unlocked position.Note: black rotation wings must be in the unlocked position to remove the inserter.Pull back first, rock hand medial and then pull up in order to clear the antirotation feature" as the device was not returned, a definite root cause cannot be determined.Possible root causes from the risk table include excessive cantilever force, excessive axial force during removal, difficulty removing the inserter and/or implant, insufficient distraction, and/or user cannot visually assess implant/instrument position or trajectory.Status and location of the device is currently unknown.
Event or Problem Description
It was reported that during surgery a tritanium tl inserter would not release the implant at the desired location.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay by utilizing another inserter and implant.

• Brand Name: INSERTER TRITANIUM TL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10786660
• Report Number: 0009617544-2020-00187
• Device Sequence Number: 2904191
• Product Code: LXH
• UDI-Device Identifier: 07613327370096
• UDI-Public: 07613327370096
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 48930000
• Device Catalogue Number: 48930000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1