MAUDE Adverse Event Report: K2M, INC. UNIVERSAL AWL; SIZE 20 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2008-90025
Medical Device Problem Codes	Mechanical Problem (1384); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.This report will capture the universal awl.
Event or Problem Description
It was reported that during a chesapeake lumber case, the universal awl 'skived' off the endplate and did not create the necessary pilot hole for the screw.This resulted in the cages at s1 and l4 having only 2 screws inserted instead of 3.Additionally, during screw insertion, the angled tapered driver came off of the screw.It was also observed that the laser markings had worn off of the expandable drill guide.This report will capture the universal awl.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog, no adverse trends were observed.It was confirmed that the awl successfully created pilot holes for four other screw holes without trouble.It is likely that the awl skived off due to user error (drill guide not used/ excess force applied/ mishandling, etc) during the surgery.

• Brand Name: UNIVERSAL AWL; SIZE 20 MM
• 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: 13655327
• Report Number: 3004774118-2022-00079
• Device Sequence Number: 20317355
• Product Code: LXH
• UDI-Device Identifier: 10888857025509
• UDI-Public: 10888857025509
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/08/2022

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: 2008-90025
• Device Catalogue Number: 2008-90025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 60 YR
• Patient Sex: Female