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

Catalog Number	8801-90034
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an ozark screw driver broke intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H5, labeled for single use, was corrected from "yes" to "no".A visual inspection performed found the tip of the screwdriver to be fractured and the device is no longer functional.The hexalobe has fractured off.Rotational deformation is observed just proximal to the fracture.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 catalog number and no adverse trends were identified.It was initially reported that the tip of ozark locking driver broke.No additional information was received regarding procedure, patient, or device usage.The rotational deformation observed just proximal to the fracture indicates that the fracture occurred during screw insertion.Ozark view and guide surgical technique 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.Note: the threaded driver must be used with the 12 inch pounds torque limiting handle.¿ due to lack of information regarding the event a definitive root cause could not be determined.Potential root causes include: not using torque limiting handle, excessive force, hard bone density.Additionally, age of device may have contributed to event.
Event or Problem Description
It was reported that the tip of an ozark screw driver broke intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were 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: 13655337
• Report Number: 3004774118-2022-00078
• Device Sequence Number: 20271094
• Product Code: LXH
• UDI-Device Identifier: 10888857400863
• UDI-Public: 10888857400863
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/23/2022

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: JKKY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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