MAUDE Adverse Event Report: K2M, INC. ADJUSTABLE INSERTER; TLIF II; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3303-90603
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the aleutian tlif ii inserter became stuck during insertion and broke at the tip.The procedure was completed successfully without surgical delay.No adverse consequences were reported.
Event or Problem Description
It was reported that the aleutian tlif ii inserter became stuck during insertion and broke at the tip.The procedure was completed successfully without surgical delay.No adverse consequences were reported.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned for evaluation.However, pictures of the reported device were received from the field.From the provided images, deformation and fracture were observed at the distal end of the instrument.Complaint history records were reviewed for this lot, and one similar complaint was identified.It is possible that off-axis maneuvers during surgery may have affected the distal end of the instrument.However, a conclusive cause for the failure mode could not be determined as the device was not returned for evaluation.H3 other text : device not returned for evaluation.

• Brand Name: ADJUSTABLE INSERTER; TLIF II
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 12050192
• Report Number: 3004774118-2021-00188
• Device Sequence Number: 17250455
• Product Code: LXH
• UDI-Device Identifier: 10888857157668
• UDI-Public: 10888857157668
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 3303-90603
• Device Catalogue Number: 3303-90603
• Device Lot Number: KUCU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1