MAUDE Adverse Event Report: K2M, INC. ANGLED LATERAL INSERTER; 25; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SP-3140
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that an aleutian lateral system angled lateral insert tip got stuck in the cascadia lateral interbody.The surgeon was unable to remove the inserter from the implant after multiple attempts.The surgeon had to snap the tip off of the inserter and leave it in the inner threads of the cascadia lateral interbody, which remained in the patient.The surgery was completed successfully using a straight inserter for the second interbody, followed up with screws.This event resulted in a 30 minute surgical delay and without any adverse consequences to the patient.
Event or Problem Description
It was reported that an aleutian lateral system angled lateral insert tip got stuck in the cascadia lateral interbody.The surgeon was unable to remove the inserter from the implant after multiple attempts.The surgeon had to snap the tip off of the inserter and leave it in the inner threads of the cascadia lateral interbody, which remained in the patient.The surgery was completed successfully using a straight inserter for the second interbody, followed up with screws.This event resulted in a 30 minute surgical delay and without any adverse consequences to the patient.
Additional Manufacturer Narrative
D.4 and d.9 were updated to reflect product information upon product return.
Additional Manufacturer Narrative
Visual inspection: the device was inspected and was confirmed that the distal tip of the angled lateral inserter was fractured.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per cascadia lateral 3d surgical technique: interbody selection an appropriately sized implant is chosen at the discretion of the surgeon.Implants are available in 22 mm footprints (anterior to posterior) in parallel, 8, 12, and 15 lordosis configurations, heights from 8-16 mm, and lengths from 45-60 mm (p.10).As reported, the user was twisting the instrument during implantation or the maneuvering pulled the threaded tip sideways, which applied excessive tightening force to the assembly and may have damaged the instrument.Excessive tightening force could have compressed and crushed the tabs of the inserter between the instrument and the implant, causing the initial jamming.As a result, the alleged failure mode was confirmed, and the most likely cause of the issue was determined to have been excessive tightening force.
Event or Problem Description
It was reported that an aleutian lateral system angled lateral insert tip got stuck in the cascadia lateral interbody.The surgeon was unable to remove the inserter from the implant after multiple attempts.The surgeon had to snap the tip off of the inserter and leave it in the inner threads of the cascadia lateral interbody, which remained in the patient.The surgery was completed successfully using a straight inserter for the second interbody, followed up with screws.This event resulted in a 30 minute surgical delay and without any adverse consequences to the patient.

• Brand Name: ANGLED LATERAL INSERTER; 25
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10717833
• Report Number: 3004774118-2020-00282
• Device Sequence Number: 3312375
• Product Code: LXH
• UDI-Device Identifier: 10888857421080
• UDI-Public: 10888857421080
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 01/18/2021

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: SP-3140
• Device Catalogue Number: SP-3140
• Device Lot Number: KNRH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 10/22/2020; 12/30/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/17/2020; 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1