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

Model Number	2008-90025
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a chesapeake anterior lumbar awl was bent outside the operating room.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.
Additional Manufacturer Narrative
The device was visually inspected and tip deformation was confirmed.The edge of the tip remains sharp despite the deformation, consistent with force being applied perpendicular to the device while it is not fully seated.Complaint history records were reviewed for this catalog number, no adverse trends were identified.A conclusive root cause cannot be established.Plausible contributing factors include the use of excessive force during bone preparation and material weakening over time from continuous use of the device.
Event or Problem Description
It was reported that a chesapeake anterior lumbar awl was bent outside the or.There was no associated procedure with this event, therefore, no adverse consequences to any patients were seen.

• 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: 14415870
• Report Number: 3004774118-2022-00184
• Device Sequence Number: 5489878
• Product Code: LXH
• UDI-Device Identifier: 10888857025509
• UDI-Public: 10888857025509
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/17/2022

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
• Device Lot Number: KUNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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