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

Catalog Number	8801-90034
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an ozark screw driver wouldn't retain the screw intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
A visual inspection was performed.The threaded tip of the driver has fractured off.The threaded portion fracture is just proximal to the tip of the hexalobe.Device history records were reviewed for this lot, and no relevant manufacturing issues were identified.Complaint history records were reviewed for this lot and catalog number, no adverse trends were identified.Initial report states that the driver will not retain the screw and visual inspection confirmed the threaded tip of the driver has fractured off.It was also reported via follow up that the blue handle was used with the driver during screw placement.The device was not used at a difficult angle or with excessive force.The most likely cause of the reported event was determined to be due to the use of the incorrect handle during screw insertion.The grey torque limiting handle must be used with the threaded driver.The torque limiting handle is designed to protect the driver from excessive torque, which can lead to driver damage during screw insertion.
Event or Problem Description
It was reported that the tip of an ozark screw driver wouldn't retain the screw 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: 13559477
• Report Number: 3004774118-2022-00067
• Device Sequence Number: 3818822
• 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): 05/18/2022

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: JDCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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