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

Model Number	2008-90028
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the tip of a chesapeake al awl fractured off intra-operatively, and that the tip remained in the implanted cage.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 the tip of a chesapeake al awl fractured off intra-operatively, and that the tip remained in the implanted cage.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.H3 other text : device location unknown.

• Brand Name: 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): STRYKER SPINE-LEESBURG; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16898775
• Report Number: 3004774118-2023-00055
• Device Sequence Number: 5372259
• Product Code: LXH
• UDI-Device Identifier: 10888857025530
• UDI-Public: 10888857025530
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: 2008-90028
• Device Catalogue Number: 2008-90028
• Device Lot Number: CNFV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• 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