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	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ozark screwdriver was broken intra-operatively.No adverse consequences, surgical delay or medical intervention were reported. the procedure was completed successfully.
Additional Manufacturer Narrative
Visual inspection was performed and it was found that the star tip of the driver was deformed and fractured.The deformation observed is rotational and indicates that there was excessive torque applied to the driver during screw insertion.The deformation resulted in the fractures occurring in the inner indents of the star pattern that engages with the screw head.Complaint history records were reviewed for this lot, one similar complaint was identified.The ozark view and guide surgical technique was reviewed and the following relevant information was identified: 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.Due to the degree of deformation observed and location of fracture, the root cause was determined to be excessive torque applied during screw insertion.It was not reported if the 12 in-lb torque limiting handle was used or not.Torque limiting handle is designed to protect the driver, not using it can result in fracture observed.Additionally, it was reported that a similar event occurred with the same device cat# during the same procedure.The failure mode, although similar, was different as the threaded retention tip fractured.The combination of 2 driver fracturing during the same procedure with different components fracturing, indicates that the most likely potential cause was excessive torque and/or lack of use of torque limiting handle.
Event or Problem Description
It was reported that 2 ozark screwdrivers broke at the tip intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.This report captures the first of the two screwdrivers.

• 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: 12304695
• Report Number: 3004774118-2021-00244
• Device Sequence Number: 3970481
• 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): 11/23/2021

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 Catalogue Number: 8801-90034
• Device Lot Number: KTDR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/23/2021
• 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: Unknown