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

Catalog Number	5101-90161
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	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
It was reported that an everest xt locking screw inserter was "clicking" and kept loosening from the screw intra-operatively.Surgery was successfully completed with another inserter.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that an everest xt locking screw inserter was "clicking" and kept loosening from the screw intra-operatively.Surgery was successfully completed with another inserter and a 20 minute surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per surgical technique: cleaning/reprocessing - k2m reusable devices are supplied non-sterile and must be thoroughly cleaned prior to sterilization.Thermal disinfection may be also be performed to render the devices safe for handling however sterilization must be performed as a final step in reprocessing.Point of use - contaminated instruments should be wiped clean of visible soil at the point of use, to prevent drying of soil and contaminants in and on the device.Flush cannulated devices with sterile or purified water to prevent the drying of soil and/or debris on the inside.Factors such as consistent use of this instrument throughout its lifetime, or previous misuse of instrument may lead to the reported failure at the tip.Since the device was not returned, a conclusive root cause could not be determined.

• Brand Name: LOCKING SCREW INSERTER, XT, CANNULATED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10521797
• Report Number: 3004774118-2020-00207
• Device Sequence Number: 3155547
• Product Code: LXH
• UDI-Device Identifier: 10888857279414
• UDI-Public: 10888857279414
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/19/2021

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 Catalogue Number: 5101-90161
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1