MAUDE Adverse Event Report: K2M, INC. UNIVERSAL TAPERED DRIVER; SIZE 10; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	3608-90075
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a chesapeake universal tapered driver would not retain the screw.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Event or Problem Description
A company representative reported that a chesapeake universal tapered driver would not retain the screw.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
The device was visually inspected and minor tip deformation was observed with normal wear and tear.The device was functionally tested and it was able to engage with and drive a screw as normal.There is slight resistance when twisting more than 360 degrees but the device is not jamming.A review of complaint history associated with the subject catalog and lot number was performed, and no adverse trends were observed.The tip deformation likely caused the driver to have difficulties engaging the screw in the or causing this failure and while the minor tip deformation could be due to normal wear and tear, an exact cause of the reported event could not be determined.

• Brand Name: UNIVERSAL TAPERED DRIVER; 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: 14418780
• Report Number: 3004774118-2022-00191
• Device Sequence Number: 17505695
• Product Code: LXH
• UDI-Device Identifier: 10888857082960
• UDI-Public: 10888857082960
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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 Model Number: 3608-90075
• Device Catalogue Number: 3608-90075
• Device Lot Number: KXXE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/12/2022
• 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