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 2 ozark screwdrivers were broken intra-operatively.No adverse consequences, surgical delay or medical intervention were reported.  the procedure was completed successfully.This report captures the second of two screwdrivers.
Additional Manufacturer Narrative
Visual inspection was performed and found the threaded distal screw retention tip to be fractured from the tip of driver.The fracture location indicates excessive torque applied during screw insertion, as the intended purpose of the retention tip is to hold screw to driver.Complaint history records were reviewed for this lot, one similar complaint was identified.Due to the location of the fracture the most likely cause of this event 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.The torque limiting handle is designed to protect the driver, not using it can result in the fracture which was 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 star pattern that engages in the screw head had deformed and fractured.The combination of 2 drivers 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 second 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: 12304775
• Report Number: 3004774118-2021-00245
• Device Sequence Number: 3532589
• 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: 08/13/2021
• 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