MAUDE Adverse Event Report: K2M, INC. SCREW DRIVER W/ THREAD; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	8801-90034
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that an ozark driver was received with a fractured thread on the tip.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
Visual inspection was performed and found the distal end of the driver to be deformed rotationally.Deformation location and direction indicates deformation most likely occurred in a previous case during screw insertion.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Device was manufactured in june 2018 and was over 3 years old at the time of the reported event.No similar complaints for the reported lot number were identified.Device stg was reviewed: once the screw hole is prepared and the appropriately sized screw is selected, screws can be inserted into the plate using the size 10 tapered driver or the size 10 threaded driver.To use the size 10 threaded driver: the size 10 threaded driver has a threaded distal tip to aid in the retention of the screws during insertion.Attach the proximal end of the threaded driver to the torque limiting handle.Insert the distal end of the threaded driver into the screw head and turn the knob clockwise to engage screw.The threaded driver must be used with the 12-in lbs torque limiting handle.The threaded driver will not work with the fast guide the most likely cause of the reported event was determined to be multi-factorial.Device age and previous excessive torque most likely both contributed to the event.Lack of use of the torque limiting handle may have potentially contributed to event.
Event or Problem Description
A company representative reported that an ozark driver was received with a fractured thread on the tip.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.

• Brand Name: SCREW DRIVER W/ THREAD; SIZE 10
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12857660
• Report Number: 3004774118-2021-00366
• Device Sequence Number: 11766775
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 8801-90034
• Device Lot Number: GUAJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown