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

Model Number	SP-4212
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an ozark screwdriver fractured during use.All broken components were removed and the procedure was completed successfully with no reported surgical delay or adverse consequence to the patient.
Additional Manufacturer Narrative
Visual: visual inspection was performed and found the tip to be fractured.Inner shaft threaded tip is still in tact, but the shaft is bent approximately half way down the shaft.Complaint history records were reviewed for this lot, and no similar complaints were identified.Ozark stg provides: screw insertion - 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 tapered driver: the size 10 tapered driver has a tapered, self-retaining tip (stab-and-grab) to aid in insertion of the screws.Attach the proximal end of the driver to the spin top handle.Engage the stab-and-grab feature by inserting the driver into the screw.If preferred, the selected screw can be inserted into the vertebral body via the fast guide when using the guide plate.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.It was reported that the bone was hard and that the driver was most likely over torqued during screw insertion.Additionally, the inner shaft deformation may indicate potential over torqueing of driver.The most likely cause of the reported event was determined to be due to the reported excessive torque applied during insertion.Device must not exceed 12 in-lbs of torque.Device handle is built in thus surgeon must ensure excessive torque is not applied.Patients hard bone most likely contributed to excessive torque applied.
Event or Problem Description
It was reported that the tip of an ozark screwdriver fractured during use.All broken components were removed and the procedure was completed successfully with no reported surgical delay or adverse consequence to the patient.

• 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: 12450365
• Report Number: 3004774118-2021-00272
• Device Sequence Number: 11638770
• Product Code: LXH
• UDI-Device Identifier: 10888857488649
• UDI-Public: 10888857488649
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/22/2021

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 Model Number: SP-4212
• Device Catalogue Number: SP-4212
• Device Lot Number: MTBT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/22/2021
• 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: Female