MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2901-90098
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two everest locking screw inserter tips jammed intra-operatively.The drivers cross threaded with screw and tampered the threads.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report represents the second of the two inserters.
Event or Problem Description
It was reported that two everest locking screw inserter tips jammed intra-operatively.The drivers cross threaded with screw and tampered the threads.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.This report represents the second of the two inserters.
Additional Manufacturer Narrative
Visual inspection: upon review of the part, it was observed that the distal tip of the inner shaft showed signs of damage to the male hexalobe feature.Functional inspection: functional analysis revealed that the tip does not fully engage the hexalobe feature of a sample everest screw.Material analysis: the instrument was sent to imr materials analysis testing.No non-conformances were observed on the material during testing.It was suggested that these hexalobe tips may have been deformed due to incomplete insertion of the hexalobe tip on to the screw, or off-axis maneuvering of the instrument during surgical procedures.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot and 4 similar complaints were identified.Per everest deformity surgical technique: after the pedicle pathway has been prepared and proper screw length and diameter have been determined, the appropriate implant is selected and loaded for screw insertion using the everest deformity screw inserter.The everest deformity screw inserter will work with both polyaxial and uni-planar everest screws.To load the everest deformity screw inserter, grasp the implant by the shaft of the screw and apply a downward force to engage the screw into the hexalobe fitting of the screw inserter shaft.Thread the silver knob in a clockwise direction until the implant is securely attached to the inserter.Pull the silver knob toward the handle to lock the inserter onto the screw.To disengage the screw inserter, pull down on the silver knob, gently turn in a counter-clockwise direction, and remove the inserter from the surgical field.Note: uniplanar screws are available upon request and may be selected if there is additional rotational deformity to be addressed (p.8).Ensuring that the screw is securely engaged in the inserter tip can assist in distributing forces evenly throughout the screw/inserter interface and reduce torque overloading.

• Brand Name: LOCKING SCREW INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10607326
• Report Number: 3004774118-2020-00221
• Device Sequence Number: 3830845
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 01/20/2021

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 Catalogue Number: 2901-90098
• Device Lot Number: GUYU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1