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

Model Number	8801-90034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an ozark screwdriver fractured during intra-operative screw insertion.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The device was visually inspected and the threaded inner tip of the driver is fractured off.Distal hexalobe of driver is slightly deformed rotationally.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.It was further reported via follow up communication that the reported event occurred during screw insertion.The blue spin top handle was used and excessive force was not applied.Patient had hard bone.Ozark surgical technique guide was reviewed: ¿the 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.¿.The most likely cause of the reported event was determined to be due to not using the 12 in-lb torque limiting handle with the threaded driver.Torque limiting driver will prevent the tip of the driver from experiencing too much torque (over 12 in-lbs) which can damage the driver.The patients hard bone quality may have contributed to the event by causing the driver to be over torqued without a torque limiting handle.
Event or Problem Description
It was reported that the tip of an ozark screwdriver fractured during intra-operative screw insertion.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• 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: 14322055
• Report Number: 3004774118-2022-00178
• Device Sequence Number: 11927318
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/29/2022

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 Model Number: 8801-90034
• Device Catalogue Number: 8801-90034
• Device Lot Number: TCFU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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