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

Catalog Number	8801-90034
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the ozark threaded screw driver was observed to be deformed upon inspection.There was no procedure associated with this event.No surgical delay nor adverse consequences were reported.
Event or Problem Description
It was reported that the tip of the ozark threaded screw driver was observed to be deformed upon inspection.There was no procedure associated with this event.No surgical delay nor adverse consequences were reported.
Additional Manufacturer Narrative
A visual inspection was performed which found the distal end of the driver to be deformed rotationally.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.It was reported that when opening up a set before a case, the driver was found to have a deformed tip.Deformation location and direction indicates deformation most likely occurred in a previous case during screw insertion.The ozark surgical technique guide was reviewed: ¿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.¿ ¿note: the threaded driver must be used with the 12-in lbs.Torque limiting handle.If the instrument is subjected to a force greater than 12 in-lbs., then it may result in device damage.¿ the most likely cause of the reported event was determined to be due to previous excessive torque applied during screw insertion.Lack of use of the torque limiting handle may have potentially contributed to the event.

• 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: 12844734
• Report Number: 3004774118-2021-00361
• Device Sequence Number: 4351905
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: NXJX
• 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: 11/19/2021
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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