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

Catalog Number	2901-90098
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon attempted screw insertion, the tips of two everest locking screw inserters 'stripped'.There were no adverse consequences to the patient.The procedure was completed successfully using an alternatively available instrument.This record represents the first of the two locking screw inserters.
Event or Problem Description
It was reported that upon attempted screw insertion, the tips of two everest locking screw inserters 'stripped'.There were no adverse consequences to the patient.The procedure was completed successfully using an alternatively available instrument.This record represents the first of the two locking screw inserters.
Additional Manufacturer Narrative
Visual inspection: the device was inspected and was found to have had a deformed distal tip.The hexalobe tip was deformed in a manner which is consistent with slippage or stripping of the driver head during instrument use.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per everest 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.It was communicated that difficult patient anatomy may have contributed to the issue.As a result, the most likely cause of the issue was determined to have been device failure due to difficult patient anatomy.

• 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: 10497210
• Report Number: 3004774118-2020-00197
• Device Sequence Number: 3117851
• Product Code: LXH
• UDI-Device Identifier: 10888857040564
• UDI-Public: 10888857040564
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/24/2020

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: KCAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/31/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1